Phase III washout for Adocia

Adocia announced the topline results for its Phase III trial of diabetic foot ulcer treatment BioChaperone PDGF. The product did not meet the primary endpoint in this Phase III trial conducted in India, the Lyon-based company said. CEO Gérard Soula did not hold back his consternation: We are surprised and disappointed by these topline results, which are inconsistent with previously reported positive Phase 1/2 clinical results.

The randomised, double-blind, multicentre, outpatient study 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 two days for a maximum of 20 weeks with either a placebo spray (saline solution) or a spray containing BC PDGF. However, after this time, BC PDGF did not perform better than the placebo and therefore did not meet the primary endpoint.

Now, Adocia has decided to stop development in this indication, focusing instead on injectable therapeutics for the treatment of diabetes. Diabetic foot ulcer has proved an extremely difficult condition to address, as seen in multiple recent late-stage clinical trial failures, stressed Soula. The main reason is the lack of uniformity in the standard of care of these types of wounds.

The company’s stock price, which had lately reacted favourably to the publication of the financial results, took a hit. Share prices fell by almost 20 percent.