Adocia said it will halt development of its diabetic foot ulcer candidate BioChaperone (BC) PDGF following its failure in a Phase III trial, joining several companies that have met with clinical failure in efforts to develop drugs for the condition.
BC PDGF—the initials stand for platelet-derived growth factor—missed the trial’s primary endpoint of statistically significant improvement over placebo in complete wound closure after 20 weeks of treatment, Adocia said.
Launched in 2014, the Phase III trial enrolled 252 diabetic patients from India with a chronic diabetic foot ulcer. In addition to standard of care, each group of patients was treated every 2 days for a maximum of 20 weeks with either a placebo spray (saline solution) or a spray containing BC PDGF.
Data from the trial was supposed to support later Phase III trial planned for the U.S. and Europe.
“We are surprised and disappointed by these topline results, which are inconsistent with previously reported positive Phase I/II clinical results. Therefore, we have initiated a thorough review of the study to analyze the discrepancy in the data” Adocia CEO Gérard Soula said in a statement.
In 2012, Adocvia trumpeted Phase I/II results showing that BioChaperone PDGF spray formulation showed a wound closure efficacy at least equivalent to that of Smith & Nephew’s marketed gel Regranex (becaplermin), at one-third the weekly dosage and when applied half as often.
Since Adocia is among several drug developers to have reported Phase III clinical trial failures for a diabetic foot ulcer product, Soula added: “We have decided to halt all development work in this indication.”
Last October, for example, Macrocure acknowledged that its lead product candidate CureXcell missed its primary endpoint of a statistically significant proportion of subjects with complete wound closure at 16 weeks and sustained complete closure for four additional weeks. The failure helped sink Macrocure shares far enough to end up on GEN’s list of Top 10 Wall Street Losers of 2015.
A month later, Derma Sciences terminated its Phase III trials for aclerastide (DSC127) after the Data Monitoring Committee for planned interim analyses concluded that the candidate was unlikely to meet its primary endpoint of closure of the target ulcer within 12 weeks of the start of treatment.
“Diabetic foot ulcer has proved an extremely difficult condition to address, as seen in multiple recent late-stage clinical trial failures. The main reason is the lack of uniformity in the standard of care of these types of wounds,” Soula added.