Regenerx Biopharmaceuticals, Inc. (RGN) announced Friday the results of its Phase II trial evaluating the efficacy of RGN-137 for the treatment of patients with chronic pressure ulcers. The drug candidate met the primary objective of being safe and well-tolerated at all three doses, with no serious adverse effects.
The Phase II trial enrolled 72 patients in fifteen U.S clinical sites to evaluate the safety, tolerability, and wound healing effectiveness of three different concentrations of the drug vs. placebo for 84 consecutive days. Patients, who had stage III or IV pressure ulcer, with a surface area between 5 and 70 cm², were eligible for the trial.
The primary objective of the study was to evaluate the safety and tolerability of the drug. Complete wound healing and rate of wound healing, between the placebo group and the three dose levels, which were the secondary objectives, did not record any significant differences.
The company said that the mid-dose level of the drug offered more rapid initiation of wound healing, compared to placebo, although it was not significantly validated.
J.J. Finkelstein, the company's president and chief executive officer, 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."
The company is also evaluating RGN-137 in a Phase II clinical trial in patients with epidermolysis bullosa.
Shares of RGN closed Thursday's regular trading session at $1.75. In pre-market hours, the stock has lost 64 cents and is trading at $1.11.
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