Date: 2016-08-25
Type of information: Results
phase: 3
Announcement: results
Company: Adocia (France)
Product: BioChaperone® PDGF-BB (Platelet Derived Growth factor)
Action
mechanism: protein. BioChaperone PDGF-BB is a formulation comprising PDGF-BB and one polymer of the proprietary BioChaperone ®platform. Adocia specifically designed this polymer to form a molecular complex with PDGF-BB to protect it from enzymatic degradation. This protection sustains the efficacy of PDGF-BB and permits to reduce the frequency of application by two and even to reduce the dose by three.
BioChaperone also stabilizes PDGF-BB in the vial at neutral pH for 3 months at room temperature. The spray device guarantees the sterility of the solution after multiple uses. This property permits to avoid the usage of antibacterial agents which are deleterious for cell proliferation.
Disease: diabetic foot ulcer
Therapeutic area: Metabolic diseases - Cardiovascular diseases
Country: India
Trial details:
Latest
news: * On August 25 2016, Adoci 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.
