Date: 2013-05-07
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the study
Company: Opsona Therapeutics (Ireland)
Product: OPN-305
Action
mechanism: monoclonal antibody. OPN-305 is a novel proprietary humanized 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 DGF following renal transplantation. OPN-305 has orphan status in the EU and USA for solid organ transplantation.
Disease: renal transplant patients at high risk of delayed graft function
Therapeutic area: Transplantation
Country:
Trial details:
Latest
news:
OPN-305 has already been administered to a number of transplant patients at high risk of delayed graft function (DGF) as part of a Pilot study before initiation of this multi-centre, randomized, double-blind, placebo-controlled, parallel group, sequential adaptive phase II trial. This pilot clearly demonstrated that 100% receptor occupancy of TLR2 on circulating monocytes was achievable and durable for the period of ischemia/reperfusion risk. It provided evidence that there was up-regulation of TLR2 in patients and provided the range of doses to be tested versus placebo in the double-blind trial. OPN-305 was well tolerated with no related adverse events. The phase II study which is expected to enrol 278 patients is an adaptive design powered to show a 15-20% absolute benefit of OPN-305 over placebo in reducing the incidence of DGF.