An independent review of blinded data from Recce Pharmaceuticals’ phase 3 Indonesian trial has identified encouraging efficacy and safety signals for its topical gel, sending shares sharply higher.
Recce Pharmaceuticals said an independent review of blinded data from its phase 3 trial in Indonesia suggests its topical gel for diabetic foot infections is showing encouraging signs of efficacy and safety, as the company prepares for a fuller assessment of the study results. The Australian-listed drug developer said a data set covering 75 patients has now been submitted to the trial’s data monitoring committee, which is expected to review unblinded results and issue recommendations around mid-November.
The study is a double-blind, placebo-controlled trial of RECCE 327 Gel, also known as R327G, in people with diabetic foot infections, a serious complication that can follow diabetic foot ulcers. Recce said 90 patients are currently enrolled and recruitment is continuing at a rate of about 4.5 patients a week. Chief executive James Graham said the review by the independent committee was an important milestone, adding that the company remains blinded to treatment allocation while investigators and patients also stay unaware of which treatment each participant received. He said that arrangement is intended to protect the scientific integrity of the trial while allowing the committee to examine safety and outcome data by treatment group. Following the announcement, Recce’s shares rose 20.7% to 35 cents, giving the company a market value of about A$88.67 million.
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