DUBLIN, Ireland -- Opsona Therapeutics, a biotechnology company focused on novel therapeutic approaches to treat autoimmune and inflammatory diseases today announced that it has initiated a phase 1 clinical trial in healthy volunteers with its lead drug candidate OPN-305. This is a first-in-human study with OPN-305.
OPN-305 is a humanised IgG4 monoclonal antibody (MAb) against Toll-Like Receptor 2 (TLR2), a target within the innate immune system, and is under development as a treatment for the prevention of Delayed Graft Function (DGF) following renal transplantation, in addition to other therapeutic indications.
Opsona has identified the prevention of Delayed Graft Function (DGF) following renal transplantation as its likely first target clinical indication for the development of OPN-305. Delayed Graft Function is a serious complication that can increase the risk of organ rejection in the immediate post-operative period of kidney transplants. Opsona believes that OPN-305 has the potential to provide a novel treatment option for a much wider variety of human diseases, including acute kidney injury, cancer, cardiovascular disease and others. Commenting on today's announcement, Mary Reilly VP Pharmaceutical Development and Operations of Opsona Therapeutics said, "We are very excited to enter the clinic with this drug candidate having managed its progression over the past few years through the development cycle."
Also commenting on today's announcement, Bernd R. Seizinger, M.D., Ph.D., Executive Chairman of Opsona Therapeutics said," OPN-305 is a first-in-class antibody against Toll-like- Receptor 2, one of the most promising novel drug targets in the innate immune system. TLR-2 has been linked to an increasing number of major human diseases, including autoimmune diseases, renal ischemia, myocardial infarction, stroke and cancer. This phase 1 study will provide the basis to explore the broad medical and commercial viability and opportunity of OPN- 305 in a variety of indications with unmet medical needs."
The phase 1 study is a single centre, prospective, randomised, double blind, placebo-controlled, sequential, dose escalating phase I study to assess the safety and tolerability, pharmacokinetics and pharmacodynamics of intraveneously infused single doses of OPN-305 in healthy subjects.
Opsona was recently awarded €5.9 million from the European Commission to lead a European framework 7 (FP7) consortium of research and clinical groups (termed MABSOT*) to advance this clinical trial. Following successful completion of the phase 1 trial, the Company plans to conduct a prospective randomized placebo-controlled phase 2 trials in the prevention of DGF to be initiated in 2012.