Adocia has announced topline results from a Phase 3 clinical trial of BioChaperone PDGF (BC PDGF) in the treatment of diabetic foot ulcer (DFU), which was conducted in India.
In this trial, BC PDGF did not meet the primary endpoint of a statistically significant improvement over placebo in complete wound closure after twenty weeks of treatment. There were no safety concerns attributed to BC PDGF.
“We are surprised and disappointed by these topline results, which are inconsistent with previously reported positive Phase 1/2 clinical results. Therefore, we have initiated a thorough review of the study to analyse the discrepancy in the data” said Gérard Soula, CEO of Adocia. “However, 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. In this context, we have decided to halt all development work in this indication. As announced previously, we are focusing our efforts on our portfolio of innovative injectable therapeutics for the treatment of diabetes.”
This randomized, double-blind, multicenter, outpatient study enrolled 252 diabetic patients from India with a chronic DFU. In addition to standard of care, each group of patients was treated every two days for a maximum of 20 weeks with either a placebo spray (saline solution) or a spray containing BC PDGF.