Velicept Therapeutics Announces Positive Top-Line Phase 2b Results for Solabegron in the Treatment of Overactive Bladder (OAB)

• Study VEL-2002 further validates solabegron’s potential for best-in-class efficacy across multiple primary and secondary endpoints

Wayne, PA - Velicept Therapeutics, a privately-held specialty pharmaceutical company dedicated to the development of best-in-class compounds for the treatment of urological and gastrointestinal disorders, announced that its next generation beta-3 adrenoceptor agonist solabegron met the primary endpoint in VEL-2002, a Phase 2b study in patients with overactive bladder (OAB). In the study, twice-daily administration of solabegron demonstrated a statistically significant improvement compared to placebo at week 12, as measured by the mean change in number of micturitions per day, the study’s primary endpoint. Solabegron also demonstrated statistical significance across multiple secondary endpoints including percent reduction of urge urinary incontinence episodes, dry rate, and urgency episodes.

The 12-week placebo-controlled VEL-2002 study enrolled 435 women ages 18 to 80 suffering from OAB. Solabegron was generally well-tolerated. Treatment emergent adverse events and serious adverse events were infrequent and comparable between the solabegron and placebo-treated groups. Velicept plans to submit the data from the VEL-2002 study for presentation at upcoming scientific meetings.

“We are encouraged by these positive top-line results for VEL-2002 as they are consistent with what we’ve seen in a prior study with solabegron undertaken by GSK and further validate the potential for best-in-class efficacy and improved safety for patients with OAB,” said James Walker, President and Chief Executive Officer, Velicept Therapeutics. “We look forward to the results of our second study, which will help us finalize our plans for moving forward with a pivotal Phase 3 program early next year.”

Velicept has also developed a novel, once-daily formulation of solabegron which is being evaluated in an ongoing Phase 2b study (VEL-2001). VEL-2001 has completed enrollment and the company expects to announce top-line results in the second quarter of this year.

About Solabegron

Solabegron is a highly potent and selective beta-3 adrenoceptor agonist being investigated for overactive bladder (OAB) and irritable bowel syndrome (IBS). A Phase 2 study of solabegron in OAB, previously conducted by GlaxoSmithKline, evaluated a twice-daily dose in 258 patients with moderate to severe incontinence experiencing an average of 4.5 wet episodes per day. Results demonstrated a statistically significant improvement with solabegron as compared to placebo. Furthermore, the Phase 2 study also indicated a safety and tolerability profile for solabegron that was similar to placebo.

About Velicept

Velicept Therapeutics, Inc. is a privately-held, clinical development company focused on advancing best-in-class compounds for the treatment of urological and gastrointestinal disorders. Its lead product, solabegron, is a highly potent and selective beta-3 adrenoceptor agonist being investigated for overactive bladder (OAB) and irritable bowel syndrome (IBS). For more information, visit www.velicept.com.

Contacts

Media:

W2Otwist

Sheryl Seapy, (213) 262-9390

sseapy@twistmktg.com

Velicept Therapeutics Raises an Additional $15 Million in Series B Round

• Additional Funding to Advance Phase 2b Development Program in OAB-

• Enrollment for Second Phase 2 Study Well Underway-

• Issuance of U.S. Patent No. 10,065,922 Further Expands Velicept’s Portfolio Covering Solabegron

MALVERN, Pa. - Velicept Therapeutics, a privately-held clinical stage pharmaceutical company dedicated to the development of best-in-class compounds for the treatment of urological and gastrointestinal disorders, announced today it has closed on the expansion of a Series B financing bringing an additional $15 million to support completion of the two ongoing Phase 2b studies, as well as Phase 3 enabling work. The financing led by Samsara BioCapital, included existing investors CDK Associates, LLC; Fountain Healthcare Partners Fund II, L.P.; Longitude Venture Partners II, L.P; and founding investor Becker Ventures. Cory Freedland, a Principal with Samsara BioCapital, has joined the Company’s Board of Directors.

“We are pleased with our progress in advancing the development of solabegron. This financing provides us the capital necessary to complete the robust Phase 2 program and ready the program to enter Phase 3,” said Dr. James Walker, President and Chief Executive Officer, Velicept Therapeutics. “These are important steps as we continue to execute on our plan to deliver an improved next generation therapy to women and men suffering from overactive bladder.”

Velicept also announced that VEL2001, the second of two Phase 2b clinical studies designed to evaluate two doses of a novel once daily time-dependent release formulation of solabegron in patients with overactive bladder (OAB), was initiated in July with enrollment progressing to plan. The primary objective of the study is to evaluate the mean change in number of micturitions per day as measured by patients in an e-diary. The formulation was engineered to optimize efficacy in a convenient once daily dose. Together with the BID study currently underway (VEL2002), the comprehensive Phase 2 program will explore the full dose range for solabegron with the goal of delivering best in class efficacy in the treatment of OAB.

The multicenter, randomized, double-blind, vehicle-controlled Phase 2b study will enroll 375 adult women ages 18 to 80 with signs and symptoms of overactive bladder from 90 centers across North America. Patients will receive either low or high dose of solabegron once daily or placebo for 12 weeks.

Additionally, the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,065,922 with 126 claims, directed to solid solabegron zwitterion. The patent will expire February 23, 2037, inclusive of patent term adjustment. This issued U.S. Patent is part of an intellectual property portfolio, which includes other issued patents, and numerous patent applications in the U.S. and major international markets directed to solabegron for the treatment of OAB.

About Solabegron

Solabegron is a highly potent and selective beta-3 adrenoceptor agonist being investigated for overactive bladder (OAB) and irritable bowel syndrome (IBS). A Phase 2 study of solabegron in OAB, previously conducted by GlaxoSmithKline, evaluated a twice-daily dose in 258 patients with moderate to severe incontinence experiencing an average of 4.5 wet episodes per day. Results demonstrated a statistically significant improvement with solabegron as compared to placebo. Furthermore, the Phase 2 study also indicated a safety and tolerability profile for solabegron that was similar to placebo.

About Velicept

Velicept Therapeutics, Inc. is a privately held, clinical stage pharmaceutical company focused on advancing best-in-class compounds for the treatment of urological and gastrointestinal disorders. Its lead product, solabegron, is a highly potent and selective beta-3 adrenoceptor agonist being investigated for overactive bladder (OAB) and irritable bowel syndrome (IBS). For more information, visit www.velicept.com.

Contacts

Media:

Sam Brown, Inc.

Mike Beyer, 312-961-2502

mikebeyer@sambrown.com

Velicept Therapeutics Initiates First of Two Phase 2b Dose-Ranging Studies of Solabegron in Patients with Overactive Bladder (OAB)

• First study has begun enrolling patients to evaluate twice-daily formulation
• Second study to begin in the second quarter to assess once-daily dosing with the novel QD formulation
• Issuance of U.S. Patent No. 9,907,767 further expands Velicept’s patent portfolio covering Solabegron

MALVERN, Pa. - Velicept Therapeutics, a privately-held specialty pharmaceutical company dedicated to the development of best-in-class compounds for the treatment of urological and gastrointestinal disorders, announced the initiation of the first of two Phase 2b clinical studies. 

The first study (VEL2002) will evaluate two doses of solabegron dosed twice daily in patients with overactive bladder (OAB). The primary objective of the study is to evaluate the mean change in number of micturitions per day as measured by patients in an e-diary.

The Company has finalized a novel once daily formulation of solabegron which will be evaluated in a second study. The formulation was engineered to optimize efficacy in a convenient once daily dosing. This study (VEL2001) will initiate patient enrollment in the second quarter of this year.
 

Additionally the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 9,907,767, which is directed to methods related to the use of solabegron to treat overactive bladder. The patent issued with 42 claims directed to methods of treating overactive bladder, measured by an increase in voided volume, using a therapeutically effective amount of solabegron or its derivatives. This issued U.S. Patent is part of a robust intellectual property portfolio that includes numerous issued patents and pending patent applications in the U.S. and major international markets directed to solabegron, its use for the treatment of overactive bladder, once daily formulations designed to optimize patient convenience and efficacy and methods of manufacture.
 

“We are pleased to be enrolling patients into the first of two dose ranging studies. Driving the program forward with the novel once daily formulation of solabegron as well as expanding our intellectual property estate are key steps for Velicept as we work to deliver an optimal therapy to patients suffering from OAB,” said James Walker, President and Chief Executive Officer, Velicept Therapeutics. “Many patients who suffer from overactive bladder do not achieve adequate relief on existing therapies, so we have designed our development program to maximize potential treatment options for physicians and their patients.”
 

The multicenter, randomized, double-blind, vehicle-controlled Phase 2b study will enroll 375 adult women ages 18 to 80 with signs and symptoms of overactive bladder from 90 centers across North America. Patients will receive either 125mg or 175mg of solabegron twice daily or placebo for 12 weeks.
 

About Solabegron
Solabegron is a highly potent and selective beta-3 adrenoceptor agonist being investigated for overactive bladder (OAB) and irritable bowel syndrome (IBS). A Phase II study of solabegron in OAB, previously conducted by GlaxoSmithKline, evaluated a twice-daily dose in 258 patients with moderate to severe incontinence experiencing an average of 4.5 wet episodes per day. Results demonstrated a statistically significant improvement with solabegron as compared to placebo. Furthermore, the Phase II study also indicated a safety and tolerability profile for solabegron that was similar to placebo.
 

About Velicept
Velicept Therapeutics, Inc. is a privately held, clinical development company focused on advancing best-in-class compounds for the treatment of urological and gastrointestinal disorders. Its lead product, solabegron, is a highly potent and selective beta-3 adrenoceptor agonist being investigated for overactive bladder (OAB) and irritable bowel syndrome (IBS). For more information, visit www.velicept.com.
 

Contacts
Media:
Sam Brown, Inc.
Mike Beyer, 312-961-2502
mikebeyer@sambrown.com