AbbVie Acquires Syndesi Therapeutics, Strengthening Neuroscience Portfolio

Expands AbbVie's neuroscience portfolio, adding first-in-class modulators of the synaptic vesicle protein 2A, including lead molecule SDI-118 currently in Phase 1b studies

Novel mechanism will be evaluated for the potential to mitigate synaptic dysfunction associated with cognitive deficits across a range of neuropsychiatric and neurodegenerative disorders

AbbVie (NYSE: ABBV) today announced it has completed the acquisition of Syndesi Therapeutics SA, which will help to expand AbbVie's neuroscience portfolio. This acquisition gives AbbVie access to Syndesi's portfolio of novel modulators of the synaptic vesicle protein 2A (SV2A), including its lead molecule SDI-118. The mechanism is currently being evaluated for the potential treatment of cognitive impairment and other symptoms associated with a range of neuropsychiatric and neurodegenerative disorders, such as Alzheimer's disease and major depressive disorder.

"There is a major unmet need for new therapies that can help improve cognitive function in patients suffering from difficult-to-treat neurologic diseases," said Tom Hudson, M.D., senior vice president, R&D, chief scientific officer, AbbVie. "With AbbVie's acquisition of Syndesi, we aim to advance the research of a novel, first-in-class asset for the potential treatment of cognitive impairment associated with neuropsychiatric and neurodegenerative disorders."

The lead molecule, SDI-118, is a small molecule currently in Phase 1b studies, which is being evaluated to target nerve terminals to enhance synaptic efficiency. Synaptic dysfunction is believed to underlie the cognitive impairment seen in multiple neuropsychiatric and neurodegenerative disorders.

"We have been impressed with the vision of AbbVie's neuroscience R&D team, who share our view on the therapeutic potential of SDI-118 in a range of neurologic diseases," said Jonathan Savidge, chief executive officer, Syndesi Therapeutics. "I am delighted with the closing of this deal. It has been a pleasure to partner with our investors to investigate the potential of SDI-118 in early clinical studies. Now, as part of AbbVie, the program is well positioned to move into later stages of clinical development."

Under the terms of the agreement, AbbVie will pay Syndesi shareholders a $130 million upfront payment with the potential for Syndesi shareholders to receive additional contingent payments of up to $870 million based on the achievement of certain predetermined milestones.

Advisors

Cleary Gottlieb Steen & Hamilton LLP acted as legal counsel to AbbVie. Goodwin Procter LLP acted as lead legal counsel, along with Deloitte Legal, Belgium, and Lazard acted as the exclusive financial adviser to Syndesi.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

About Syndesi Therapeutics

Founded in December 2017 and based in Belgium, Syndesi is a clinical stage biotechnology company pioneering the development of novel therapeutics that modulate synaptic function to relieve the symptoms of cognitive impairment. Syndesi's unique molecules act pre-synaptically to enhance synaptic efficiency by positively modulating the function of synaptic vesicle protein 2A (SV2A), which plays a central role in regulating neurotransmission.

Syndesi was created through a partnership between UCB Biopharma SRL and a syndicate of Belgian and international investors to further develop novel SV2A modulators that had been originally discovered by UCB. Syndesi's Series A financing was co-led by Novo Holdings together with Fountain Healthcare Partners, with participation from Johnson & Johnson Innovation – JJDC, Inc., SRIW (Société Régionale d'Investissement de Wallonie), V-Bio Ventures and Vives Fund, along with UCB Ventures. The company has also benefited from support from the Walloon Region. The lead molecule, SDI-118, was discovered by UCB before being out-licensed to Syndesi as of 2018.

Syndesi Therapeutics announces commencement of dosing in clinical trial of SDI-118 in elderly subjects with cognitive impairment

Syndesi Therapeutics SA, a clinical stage biotechnology company developing novel modulators of the synaptic vesicle protein SV2A for the treatment of cognitive impairment, announces that dosing has commenced in the first clinical trial in the next phase of development of its lead compound, SDI-118.

The double-blind, placebo-controlled, parallel group study will evaluate the safety, tolerability, and pharmacodynamics of SDI-118 in elderly male and female participants with cognitive decline. Eligibility for enrollment in the study includes self-reported and companion-confirmed decline in memory, as well as a below average performance on a delayed word recall test as an objective measurement of cognitive deficit. The study includes fMRI imaging, both at rest and during cognitive tasks, as a biomarker of drug effect, as well as a battery of cognitive tests conducted at baseline and following approximately two weeks dosing with SDI-118 or placebo. The design of the study was the subject of a presentation at the recent European College of Neuropsychopharmacology (ECNP) annual conference (1), held 2-5 October 2021

Subjects are currently being enrolled at St Pancras Clinical Research in London, with additional sites in Germany to be initiated shortly.

Commenting on the initiation of the study, Jonathan Savidge CEO of Syndesi said “We are very excited to get this proof of principle study with SDI-118 underway to explore the potential of this novel synaptic mechanism to mitigate cognitive impairment due to underlying synaptic loss.”

Torsten Madsen, Syndesi’s CMO added “We are incorporating fMRI both before and after treatment in all subjects to translate preclinical results and build on findings from fMRI measures in a prior clinical study. Together with the battery of cognitive tests, this will provide a wealth of information on this novel synaptic mechanism to optimize the late stage development program”

(1) See: https://www.ecnp.eu/Congress2021/ECNPcongress/programme/Programme#!abstractdetails/0000469100

About Syndesi Therapeutics SA

Syndesi Therapeutics is a clinical stage biotechnology company pioneering the development of novel therapeutics that modulate synaptic function to relieve the symptoms of cognitive impairment. Synaptic dysfunction, with the consequent disruption of connectivity between brain regions, underlies cognitive impairment seen in multiple CNS disorders, including Alzheimer’s Disease and schizophrenia. There is a major unmet need for new therapies that can improve cognitive function across these various CNS disorders. Unlike other therapeutic approaches, our unique molecules act pre-synaptically to enhance synaptic efficiency by positively modulating the function of synaptic vesicle protein 2A (SV2A) which plays a central role in regulating synaptic transmission. The lead molecule, SDI-118, has successfully completed three Phase I studies including PET target engagement and biomarker measures.

The company is financed by a syndicate of international and Belgian investors: Novo Holdings, Fountain Healthcare Partners, Johnson & Johnson Innovation – JJDC, Inc., SRIW (Société Régionale d’Investissement de Wallonie), V-Bio Ventures and Vives Fund, along with UCB Ventures. The Phase I program enabling the current trials was supported in part by funding from the Walloon Region.

Syndesi Therapeutics Announces Positive Results From Two Additional Phase I Studies Of Its Novel SV2A modulator SDI-118

Provides strong support for the initiation of further clinical trials in cognitive impairment

Syndesi Therapeutics SA, a clinical stage biotechnology company developing novel modulators of the synaptic vesicle protein SV2A for the treatment of cognitive impairment, announces results from two Phase I studies of its lead compound SDI-118, supporting further development of this promising molecule.

Results from a multiple ascending dose study demonstrated SDI-118 was safe and well tolerated over 14 days dosing in both young and elderly male and female participants. The highest dose tested is calculated to result in greater than 95% SV2A occupancy. Furthermore, the compound showed a very favourable pharmacokinetic profile and is suitable for once-daily dosing.

The second Phase I study investigated the effects of single doses of SDI-118 on electroencephalogram (EEG) recordings of brain activity in healthy young volunteers. The compound produced a unique profile of changes in quantitative EEG relative frequency power, consistent with the novel mechanism of action. These functional data complement the PET target engagement data generated in the first-in-human clinical study previously conducted. SDI-118 was also shown to be safe and well tolerated in this study.

The company is now preparing two further clinical studies of SDI-118 in two groups of subjects. One study will recruit participants in remission from major depressive disorder reporting cognitive impairment. The second study will recruit elderly subjects with evidence of cognitive decline. Both studies will employ fMRI imaging in addition to cognitive testing to explore the effect of SDI-118 on the cognitive deficits seen in these populations. These studies are planned to commence during H1 2021.

Commenting on the Phase I results and further clinical development plan for SDI-118, Jonathan Savidge CEO of Syndesi said “These clinical study results are very promising and provide an excellent basis for the further development of SDI-118. We look forward to commencing the two proof-of-principle clinical studies in different populations of subjects reporting a cognitive deficit with the aim to explore the therapeutic potential of SDI-118 as broadly as possible.”

About Syndesi Therapeutics

Syndesi Therapeutics is a clinical stage biotechnology company pioneering the development of novel therapeutics that modulate synaptic function to relieve the symptoms of cognitive impairment. Synaptic dysfunction, with the consequent disruption of connectivity between brain regions, underlies cognitive impairment seen in multiple CNS disorders, including Alzheimer’s Disease and schizophrenia. There is a major unmet need for new therapies that can improve cognitive function across these various CNS disorders. Unlike other therapeutic approaches, our unique molecules act pre-synaptically to enhance synaptic efficiency by positively modulating the function of synaptic vesicle protein 2A (SV2A) which plays a central role in regulating synaptic transmission. The lead molecule, SDI-118, has successfully completed three Phase I studies including PET target engagement and biomarker measures.

The company is financed by a syndicate of international and Belgian investors: Novo Holdings, Fountain Healthcare, Johnson & Johnson Innovation – JJDC, Inc., SRIW (Société Régionale d’Investissement de Wallonie), V-Bio Ventures and Vives Fund, along with UCB Ventures. The Phase I program has been supported in part by funding from the Walloon Region.

Syndesi Therapeutics progresses development of SDI-118 for cognitive impairment and expands its series A financing

Syndesi Therapeutics SA, a clinical stage biotechnology company developing novel modulators of the synaptic vesicle protein SV2A for the treatment of cognitive impairment, provides an update on the clinical development of its lead molecule, SDI-118, and announces an extension of its series A financing.

Following successful completion of a first in human single ascending dose and PET occupancy study of SDI-118, dosing in two additional Phase I studies has been completed and the data are being analyzed:

• A multiple ascending dose study to examine the safety, tolerability, and pharmacokinetics of SDI-118, following 14 days of dosing in healthy young and healthy elderly subjects.

• A single dose cross-over study investigating the effects of SDI-118 on EEG (electroencephalogram) recordings of brain activity

Results from both these studies are expected before the end of 2020.

Based on the promising progress to date, all Syndesi's existing investors - Novo Holdings, Fountain Healthcare Partners, Johnson & Johnson Innovation – JJDC, Inc., SRIW, V-Bio Ventures and Vives Fund, together with UCB Ventures - have committed to an additional tranche of Series A financing to conduct a second clinical proof-of-principle study. This study will focus on remitted depressed subjects who report a perceived deficit in cognition. Concurrently a study in elderly subjects reporting memory problems will also be run. These studies are planned to commence during H1 2021.

Commenting on the progress made with SDI-118 development and the extended financing Jonathan Savidge, CEO of Syndesi, said “We continue to be encouraged by the profile of SDI-118 as a potential treatment for a number of CNS disorders with cognitive impairment. The additional financing demonstrates the commitment from our existing investors, and allows the company to conduct a second clinical proof of principle study to more fully explore the potential benefits of SDI-118. We look forward to our next important milestones: receiving the full results from the further Phase I studies, and then commencement of two clinical proof of principle studies”

About Syndesi Therapeutics

Syndesi Therapeutics was established to develop a series of novel, pro-cognitive small molecule SV2A modulators licensed from UCB. Syndesi is investigating the potential of these molecules to improve cognition in diseases such as Alzheimer’s Disease and other dementias, as well as other conditions such as major depression and cognitive impairment associated with schizophrenia. The lead molecule, SDI-118, has successfully completed a First-in-Human Phase I study which demonstrated target engagement with PET imaging. The Phase I program has been supported in part by funding from the Walloon Region. The company is financed by a top tier syndicate of international and Belgian investors: Novo, Fountain Healthcare Partners, Johnson & Johnson Innovation – JJDC, Inc., SRIW (Société Régionale d’Investissement de Wallonie), V-Bio Ventures and Vives Fund, along with UCB Ventures. Syndesi’s financing from its extended Series A round together with non-dilutive funding from the Walloon Region totals in excess of €26M.

Syndesi Therapeutics announces the expansion of its management team with the appointment of Torsten Madsen, MD, PhD as Chief Medical Officer

Syndesi Therapeutics SA, a clinical stage biotechnology company developing novel modulators of the synaptic vesicle protein SV2A for the treatment of cognitive impairment, today announced Torsten Madsen MD, PhD has joined its management team as Chief Medical Officer.

Dr. Madsen brings over 12 years’ industry experience in CNS drug development in pharma/biotech. As a senior leader at Lundbeck in Denmark and the US he guided clinical development and registration of the anti-depressant vortioxetine. More recently, he has held senior roles at the CNS focused biotech companies Naurex and Aptinyx. Dr. Madsen earned his MD and a PhD from Copenhagen University, doing clinical training in psychiatry and general medicine and holding a postdoc position at Yale, conducting basic research in neural and synaptic plasticity.

Commenting on the appointment, Jonathan Savidge, CEO of Syndesi, said, “I’m delighted to welcome Torsten to the Syndesi team at an exciting time for the development of our lead molecule SDI-118. Torsten brings a wealth of experience specifically in CNS drug development and this will be invaluable to the company as we plan the next phases of clinical development for SDI-118.”

On his appointment as CMO, Torsten Madsen said, “It’s very exciting to be joining Syndesi to work on a novel synaptic mechanism with potential for broad applicability for treatment of cognitive impairment. I look forward to working with the Syndesi management team to progress SDI-118 into the next stage of clinical development to fully explore its potential to improve symptoms of cognitive impairment across a range of indications.”

About Syndesi Therapeutics

Syndesi Therapeutics was established to develop a series of novel, pro-cognitive small molecule SV2A modulators licensed from UCB. Syndesi is investigating the potential of these molecules to improve cognition in diseases such as Alzheimer’s Disease and other dementias, as well other conditions such as major depression and cognitive impairment associated with schizophrenia. The lead molecule, SDI-118, has successfully completed a First-in-Human Phase I study which demonstrated target engagement with PET imaging. The company has raised a total €17M in Series A funding from a syndicate of Belgium and international investors and has been awarded a total of up to €3.2 M in non-dilutive funding from the Walloon Region to support the development of the lead molecule SDI-118. For more information please visit www.syndesitherapeutics.com.

Syndesi Therapeutics announces successful completion of first-in-human Phase I study of novel SV2A modulator, SDI-118, in development for the treatment of cognitive impairment

Syndesi Therapeutics SA, a biotechnology company developing novel modulators of the synaptic vesicle protein SV2A for the treatment of cognitive impairment, today announced that the first-in-human Phase I study of its lead molecule, SDI-118, has been successfully completed.

The first-in-human Phase I study was a randomized, placebo controlled, single ascending dose study in healthy male subjects designed to investigate the safety, tolerability and pharmacokinetics of oral doses of SDI-118. The study also included PET imaging in a group of subjects to directly measure SV2A target engagement by SDI-118 in the brain.

SDI-118 was safe and well tolerated at all doses administered, with no serious adverse events. All adverse events considered to be related to SDI-118 administration were reported as mild. SDI-118 also showed favorable pharmacokinetic properties suitable for once daily dosing. Data from PET imaging following administration of a range of SDI-118 doses demonstrated a clear relationship between central SV2A occupancy and plasma exposure. Importantly, these results also demonstrated that the plasma exposures reached in the study, shown to be safe and well tolerated, provided essentially complete brain SV2A occupancy.

Commenting on the results, Jonathan Savidge CEO of Syndesi, said “We are very pleased with the excellent data generated in this first-in-human study. Single doses of the compound that result in high SV2A occupancy were shown to be safe and well tolerated. The results of the study provide an excellent basis for further clinical development, with the PET data informing the choice of doses in future studies. We will be initiating a further Phase I trial investigating multiple doses of SDI-118, including in elderly subjects.”

About Syndesi Therapeutics

Syndesi Therapeutics was established to develop a series of novel, pro-cognitive small molecule SV2A modulators licensed from UCB. In February 2018 the company announced €17M in Series A funding from a syndicate of Belgium and international investors. In March 2019, Syndesi announced the award of up to €3.2 M in non-dilutive funding from the Walloon Region to support the development of the lead molecule SDI-118 through Phase I clinical development. Syndesi is investigating the potential of these novel SV2A modulators to improve cognition in diseases such as Alzheimer’s Disease and other dementias, as well other conditions such as major depression and cognitive impairment associated with schizophrenia. For more information please visit www.syndesitherapeutics.com

Syndesi Therapeutics announces initiation of Phase I study of novel SV2A modulator, SDI-118, in development for the treatment of cognitive impairment

Belgium – Syndesi Therapeutics SA, a biotechnology company developing novel modulators of the synaptic vesicle protein SV2A for the treatment of cognitive impairment, today announced that its lead molecule, SDI-118, has entered into Phase I clinical development.

The first-in-human Phase I study is investigating the safety, tolerability and pharmacokinetics of single ascending doses of SDI-118 in healthy subjects. The study also includes PET imaging in a group of subjects to directly measure the binding of SDI- 118 to SV2A in the brain and to assess the relationship between SV2A occupancy and plasma exposure.

Jonathan Savidge, CEO of Syndesi, said “We are delighted to announce the entry of SDI- 118 into clinical development following successful completion of pre-clinical studies during the first year following Syndesi’s incorporation. Conducting PET imaging in parallel with the dose escalation provides us with highly valuable data very early in the development program. This ability to measure the degree of target engagement of our compound in humans greatly facilitates the choice of doses in future trials, de-risking one of the major challenges in CNS drug development.”

About Syndesi Therapeutics

Syndesi Therapeutics was established to develop a series of novel, pro-cognitive small molecule SV2A modulators licensed from UCB. In February 2018 the company announced €17M in Series A funding from a syndicate of Belgium and international investors. In March 2019, Syndesi announced the award of up to €3.2 M in non-dilutive funding from the Walloon Region to support the development of the lead molecule SDI- 118 through Phase I clinical development. Syndesi is investigating the potential of these novel SV2A modulators to improve cognition in diseases such as Alzheimer’s Disease and other dementias, as well other conditions such as cognitive impairment associated with schizophrenia. For more information please visit www.syndesitherapeutics.com

Syndesi Therapeutics awarded non-dilutive funding of up to €3.2M for development of its lead program, SDI-118, aimed at treating cognitive impairment

Syndesi Therapeutics SA, a biotechnology company developing novel SV2A modulators for cognitive impairment, today announced it has been granted up to EUR 3.2 M in non-dilutive funding from the Walloon Region. The funding is provided in the form of an ‘avance récupérable’ (recoverable loan), repayable under certain conditions with the majority of the repayment linked to the success of the programme.

Jonathan Savidge, CEO of Syndesi, said “We very much appreciate the Walloon Region’s ongoing support for the continued development of this program. This is an area of high unmet need where it has proven challenging to develop new therapeutics. This additional support will enable us to leverage our investor financing to expand the clinical development program for SDI-118 and maximize the chance of bringing this promising molecule to patients.”

The funding will support the development of SDI-118 through Phase I clinical studies, which will include PET imaging to directly measure the binding of SDI-118 to its target in the brain, providing key information for subsequent dose selection.

About Syndesi Therapeutics

Syndesi Therapeutics was established to develop a series of novel, pro-cognitive small molecule SV2A modulators licensed from UCB, and in February 2018 announced €17M in Series A funding from a syndicate of Belgium and international investors. Syndesi is investigating the potential of these novel SV2A modulators to improve cognition in diseases such as Alzheimer’s Disease and other dementias, as well as cognitive impairment associated with schizophrenia and other conditions. The discovery of the lead molecule, SDI-118, at UCB benefitted from prior support of the Walloon Region. For more information please visit www.syndesitherapeutics.com

Syndesi Therapeutics announces appointment of Roy Twyman MD to its Board of Directors

Syndesi Therapeutics SA, a biotech company developing novel treatments for cognitive impairment, today announced the appointment of Dr Roy Twyman to its Board as an independent non-executive Director.

Dr Twyman spent over 19 years at Janssen Research & Development (part of the Janssen Pharmaceutical Companies of Johnson & Johnson) in CNS development, holding roles of increasing responsibility. Most recently, Dr Twyman was Senior Vice President in the Neuroscience Therapeutic Area at Janssen. In this role, he had responsibility to oversee the Alzheimer’s Disease Area across all stages of R&D, including oversight of Neuroscience Experimental Medicine group covering clinical development from first time in human to proof of concept. Prior to joining Janssen in 1998, Dr Twyman held professorships in neurology at University of Michigan and University of Utah and gained his MD from University of Kentucky.

“I am delighted to welcome Roy onto Syndesi’s Board,” commented Jean Combalbert, Chair of the Board. “The fact that Syndesi has convinced an acknowledged world leader in CNS such as Roy to join the board reflects the promise of the pro-cognitive SV2A modulators for the treatment of Alzheimer's disease and other conditions. Roy’s contribution will definitively be a major asset for the company.”

Jonathan Savidge, CEO of Syndesi said “With his tremendous experience in CNS drug development, Roy brings complimentary expertise to the Board and his appointment is a major value add for the company as we prepare for Phase I entry with our lead molecule SDI-118, a small molecule modulator of SV2A that acts in a distinct way to the approved anti-epileptic compounds acting on this target.”

Commenting on his appointment, Dr Twyman noted “There is a need to explore new mechanisms that could help alleviate symptoms of cognitive impairment in dementia and other neuropsychiatric disorders. Modulation of SV2A, an important protein involved in synaptic communication between neurons, has been shown to be a successful therapeutic strategy in epilepsy. Syndesi are developing an intriguing lead molecule that modulates SV2A in a distinct way. By directly targeting synaptic dysfunction, Syndesi’s research and development effort represents a promising approach for the treatment of cognitive impairment in conditions such as Alzheimer’s Disease.”

About Syndesi Therapeutics

Syndesi Therapeutics was established to develop a series of novel, pro-cognitive small molecule SV2A modulators licensed from UCB. Syndesi is investigating the potential of these molecule to improve cognition in diseases such as Alzheimer’s Disease, other dementias and cognitive impairment associated with schizophrenia. The lead molecule, SDI-118 is anticipated to commence first in human Phase I studies in H1 2019. Syndesi announced a Series A financing round of €17M in February 2018, led by Novo Seeds and Fountain Healthcare with participation from Johnson & Johnson Innovation – JJDC, SRIW (Société Régionale d’Investissement de Wallonie), V-Bio Ventures and Vives Fund. Syndesi has been established at the Centre d’Entreprises et d’Innovation (CEI) in Louvain-la-Neuve, Belgium and is a resident company at Johnson & Johnson Innovation, JLABS (JLABS @ BE) in Beerse, Belgium.

For more information please visit www.syndesitherapeutics.com

Syndesi Therapeutics announces appointment of Jean Combalbert as Chairman of the Board

Belgium – Syndesi Therapeutics SA, a newly formed biotech company developing novel treatments for cognitive impairment, today announced the appointment of Dr Jean Combalbert as Independent Director and Chairman of the Board.

Dr Combalbert is a successful entrepreneur with more than 20 years of experience in pharmaceutical and biotech companies. He was CEO of Ogeda (formerly Euroscreen) from 2006 until its sale to Astellas Pharma Inc. in May 2017. Prior to joining Ogeda, he was VP Pharmaceutical Development at Proteus SA, Nimes, France, then Chairman & CEO of Entomed SA, Strasbourg, France. Earlier in his career, Dr Combalbert held senior positions with Sanofi in France and Galderma in France and the United States. Dr Combalbert received his PharmD and a PhD from the Université de Pharmacie, Marseille, France.

“I am impressed by the unique partnership between UCB and a syndicate of leading investors both here in Belgium and internationally that has created Syndesi to progress an intriguing new therapeutic approach for the treatment of dementia and other cognitive disorders. I am excited to work with the Board and management to support the Company in its mission to demonstrate the potential of novel modulators of SV2A for the treatment of cognitive impairment,” commented Jean Combalbert.

“It is a great pleasure to welcome Jean onto Syndesi’s Board,” said Jonathan Savidge, CEO of Syndesi. “The company is very fortunate to have attached a chairman with Jean’s experience and impressive track record in the biotech sector. I look forward to working with him, the Board and my management colleagues to evolve the Company and achieve our objectives in the clinical development of our pro-cognitive SV2A modulators.” 

About Syndesi Therapeutics
Syndesi Therapeutics was established in 2017 based on an exclusive, worldwide license from UCB to develop and commercialise a series of novel, pro-cognitive small molecule SV2A modulators. Syndesi was created to further develop these novel SV2A modulators and investigate their potential to improve cognition in diseases such as Alzheimer’s Disease, other dementias and cognitive impairment associated with schizophrenia. Syndesi announced a Series A financing round of €17M in February 2018, led by Novo Seeds and Fountain Healthcare with participation from Johnson & Johnson Innovation – JJDC, SRIW (Société Régionale d’Investissement de Wallonie), V-Bio Ventures and Vives Fund. Syndesi has been established at the Centre d’Entreprises et d’Innovation (CEI) in Louvain-la-Neuve, Belgium and is a resident company at Johnson & Johnson Innovation, JLABS (JLABS @ BE) in Beerse, Belgium. For more information please visit www.syndesitherapeutics.com

UCB and investor syndicate led by Novo Seeds launch Syndesi Therapeutics to develop novel therapeutics for cognitive disorders

• Syndesi Therapeutics to leverage UCB’s expertise in neurology drug discovery to develop potential therapeutics in cognitive disorders with a first-in-class mechanism 
• Series A financing of €17 M from a syndicate of Belgian and international investors

The creation of Syndesi Therapeutics (‘Syndesi’) was announced today as the result of a partnership between UCB and a syndicate of Belgian and international investors. The investor syndicate is led by Novo Seeds and Fountain Healthcare together with Johnson & Johnson Innovation – JJDC, Inc. (JJDC), V-BIO Ventures, the Walloon Investment Fund (SRIW) and VIVES Louvain Technology Fund. Syndesi Therapeutics has exclusively licensed a first-in-class small molecule program from UCB and the series A investment totalling €17M will fund the clinical development of the lead compound up to early proof-of-concept in humans. 
 
Syndesi Therapeutics is based in Belgium and will leverage UCB’s neurology expertise in modulating the synaptic vesicle protein SV2A. UCB’s Neuroscience researchers in Belgium have designed a unique class of novel SV2A modulators. Unlike levetiracetam and other types of SV2A modulators   discovered and developed by UCB for epilepsy, the novel compounds are devoid of anti-epileptic properties but have demonstrated robust pro-cognitive properties in preclinical models. Cognitive impairment currently being outside UCB’s strategic scope, the decision was made to have the program further developed externally to leverage its full potential. The discovery of these novel pro-cognitive SV2A modulators at UCB has benefitted from prior support of the Walloon Region, and Syndesi will use the Series A investment to build upon that work and move the lead molecule into clinical development.
 
“UCB is the world leader in SV2A research, having discovered and developed two major anti-epileptic drugs treating patients around the world. We are excited to see Syndesi develop our novel pro-cognitive SV2A modulators to create value for patients with cognitive impairment,” said Dhavalkumar Patel, UCB’s Chief Scientific Officer and Executive Vice President. “The Belgian life science ecosystem is particularly vibrant and we realised that it was the right environment to promote this research as part of our biotech model approach.”
 
Jonathan Savidge, PhD CEO of Syndesi noted “Development of these small molecules that modulate the SV2A target in a distinct manner represents an intriguing new approach for the treatment of cognitive deficits since they specifically target synaptic dysfunction, a hallmark of Alzheimer’s Disease and other indications characterized by cognitive impairment. Syndesi benefits both from UCB’s research expertise and from an impressive syndicate of experienced investors and their respective networks.”
 
“Cognitive impairment remains an area of significant unmet need for patients not only with Alzheimer’s Disease but also more broadly across a range of neurological disorders, and we are excited about the potential promise of this novel therapeutic approach,” says Morten Graugaard Døssing, Principal at Novo Seeds. “I am thrilled to be working with the company which is supported by scientists at UCB and able to leverage Janssen neuroscience expertise via a presence at the JLINX incubator, all in an effort to develop products that could one day make a meaningful difference for patients suffering from cognitive impairment.”
 
About Syndesi Therapeutics
Syndesi Therapeutics (www.syndesitherapeutics.com) has been established at the Centre d’Entreprises et d’Innovation (CEI) in Louvain-la-Neuve and will have a presence at the JLINX incubator facilities to access expertise at the Janssen campus in Beerse, Belgium. Syndesi has an exclusive, worldwide license from UCB to develop and commercialise a series of novel, pro-cognitive SV2A modulators. Syndesi will build on a rich legacy of work by UCB to further develop these novel SV2A modulators to investigate their potential to improve cognition in diseases such as Alzheimer’s Disease, other dementias and cognitive impairment associated with schizophrenia. 
 
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases in immunology and neurology. With more than 7500 people in approximately 40 countries, the company generated revenue of €4.2 billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news
 
About Novo Holdings and Novo Seeds
Novo Seeds is the early-stage investment arm of Novo Holdings (www.novoholdings.dk). Novo Holdings is a private limited liability company wholly owned by the Novo Nordisk Foundation. The company is the holding company in the Novo Group, comprising Novo Nordisk A/S, Novozymes A/S and NNIT A/S, and is responsible for managing the Foundation’s assets. In addition to being the major shareholder in the Novo Group companies, Novo Holdings provides seed and venture capital to development-stage companies, takes significant ownership positions in well-established companies within the life sciences and manages a broad portfolio of financial assets. 
 
About Fountain Healthcare Partners
Fountain Healthcare Partners (www.fh-partners.com) is a life science focused venture capital fund with €176 million ($200 million) under management. Within the life science sector, specific areas of interest to Fountain include specialty pharma, medical devices, biotechnology and diagnostics. The firm deploys the majority of its capital in Europe, with the balance in the United States. Fountain’s main office is in Dublin, Ireland, with a second office in New York. 
 
About Johnson & Johnson Innovation – JJDC, Inc. (JJDC)
Johnson & Johnson Innovation – JJDC Inc. (JJDC) is the strategic venture capital arm of Johnson & Johnson and a long-term investment partner to global healthcare entrepreneurs. Founded in 1973, JJDC continues a legacy of customizing deals for data-driven companies across the continuum of healthcare, with the goal of turning great ideas into transformative new pharmaceutical, medical device and consumer healthcare products. www.jjdc.com
 
About V-Bio Ventures
V-Bio Ventures (www.v-bio.ventures) is an independent venture capital firm specialized in building and financing young, innovative life science companies. V-Bio Ventures was established in 2015 and works closely with Belgium-based VIB, one of the world’s premier life science institutes. The fund invests throughout Europe in start-up and early-stage companies with high growth potential focusing on technologies that provide transformational improvements in the biopharmaceutical, pharmaceutical, diagnostics and agricultural sectors. 
 
About SRIW SA
SRIW Société Régionale d'Investissement de Wallonie (www.sriw.be) provides equity and/or debt to companies that generate added value and employment in Wallonia.  SRIW facilitates the region's economic development, contributing effectively to the modernisation, growth and restructuring of the businesses that make up the Walloon industrial network. In the life science sector, SRIW is investor in more than 30 companies such as I.B.A., Celyad, or Ogeda of which it recently exited. Its current portfolio fair value is above 150 million €.
 
About VIVES-Louvain Technology Fund
The VIVES Louvain Technology Fund (www.vivesfund.com) is a multi-sector technology fund which invests in the spin-offs of the Université catholique de Louvain (UCL) and start-ups in Belgium and neighboring countries. VIVES II is funded by a dozen leading Belgian and European investors such as the EUROPEAN INVESTMENT FUND (EIF), SFPI-FPIM, BNP PARIBAS FORTIS PRIVATE EQUITY BELGIUM, BPI FRANCE (France), ING BELGIUM, SOFINA, AXA BELGIUM, BELFIUS, IRD (France), NIVELINVEST, REGION BRUXELLES CAPITAL and by SOPARTEC. The objective of the fund is to invest in the development of start-ups, from validation of the technology to commercial maturity. The funds (VIVES I - €15 million and VIVES II - €43 million) are managed by SOPARTEC, UCL’s technology transfer company, member of the Louvain Technology Transfer Office.
 
For further information, UCB: 
 
Corporate Communications
France Nivelle  
Global Communications, UCB
T +32.2.559.9178 france.nivelle@ucb.com
 
Laurent Schots
Media Relations, UCB  
T+32.2.559.92.64  Laurent.schots@ucb.com
 
Investor Relations
Antje Witte          
Investor Relations, UCB
T +32.2.559.94.14 antje.witte@ucb.com
 
Isabelle Ghellynck,
 Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com