Date: 2011-07-05
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Opsona Therapeutics (Ireland)
Product: OPN-305
Action
mechanism: 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.
Disease: prevention of Delayed Graft Function (DGF) following renal transplantation
Therapeutic area: Transplantation - Renal diseases - Kidney diseases
Country:
Trial
details: 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.
Latest
news: * On July 5, 2011, Opsona Therapeutics, a biotechnology company focused on novel therapeutic approaches to treat autoimmune and inflammatory diseases, has 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.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. 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. 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.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.
