RGN-137 is a topical gel formulation of thymosin beta 4 peptide (Tâ4). The drug candidate was found to be safe and well-tolerated at all three dose levels, with no drug-related serious adverse events, which was the primary objective of the study.
Regarding the secondary objective of the study, there were no statistically significant differences observed for complete wound healing or the rate of wound healing between the placebo group and any of the three RGN-137 dose levels. The mid-dose level of RGN-137 was observed to offer more rapid initiation of wound healing when compared.
Approximately 15 US clinical sites enrolled 72 patients in a Phase II pressure ulcer clinical trial to evaluate the safety, tolerability, and wound healing effectiveness of three different Tâ4 concentrations (0.01%, 0.02%, and 0.1%) versus placebo, applied topically, once daily for up to 84 consecutive days.
J J Finkelstein, CEO of RegeneRx, said: While we are pleased that we met the primary objective of this pressure ulcer trial indicating no safety issues with RGN-137 in pressure ulcer patients, we had hoped to see an increased incidence of complete wound closure over the 84-day treatment course comparing our drug candidate to placebo.
We will continue to analyze the data and will make a decision on future development of RGN-137 for pressure ulcers after we review data from the pending Phase II venous stasis trial.