Adocia has announced positive results from its Phase II clinical trial evaluating the safety and efficacy of BioChaperone® combined with PDGF-BB for the treatment of diabetic foot ulcer.
This product has been compared with Regranex®, a commercially available hydrogel of PDGF-BB (HealthPoint, initially launched by Johnson & Johnson).
The multicentric trial has enrolled 192 patients in four groups consisting in the application of one of the three doses of BioChaperone PDGF-BB (14.5, 43.75 and 87.5 micrograms of PDGF-BB per square cm and per week) and Regranex® (43.5 micrograms per square cm and per week).
BioChaperone PDGF-BB treatments were administered once every two days whereas Regranex® was administered once a day, in compliance with the trial protocol that was approved by both US and European regulatory agencies.
The trial was not blinded due to the obvious difference in the medications, a spray for BioChaperone PDGF-BB and a gel for Regranex®. Treatments lasted 20 weeks or until complete healing.
The objective of the study was to establish the non-inferiority of BioChaperone PDGF BB compared to Regranex®.
Analysis of negative side effects, collected through the intent-to-treat (ITT) population of 192 patients did not identify any serious side effect related to the treatment.
These safety results indicate that BioChaperone PDGF-BB is well tolerated and safe at the three doses tested, for treatment periods up to 20 weeks.
The primary endpoint was the percentage of complete wound closure at 20 weeks. The rates of complete wound closure are all superior or equal to 66 per cent after 20 weeks, therefore proving success on non-inferiority criteria for the three tested PDGF-BB doses.
One of the most promising results is the 80 per cent rate of complete wound closure at 20 weeks obtained with the dose of BioChaperone containing one-third of the Regranex® equivalent of PDGF-BB dose and with only one application every two days.
For the three tested doses, secondary efficacy endpoints, i.e. the percentage of complete wound closure at ten weeks, the time to achieve complete wound closure (expressed by Kaplan-Meier median) and the percentage of reduction in wound area are all considered as non-inferior compared to Regranex®.
“We were very pleased to conduct this clinical study on this attractive product which showed undisputed efficacy,” said Dr. Arun Bal (Mumbai), principal investigator of the study.
Dr. Bal continued, “The simplicity of use of the spray as well as the frequency of application once every two days had a very positive impact on patient compliance and was very well received among patients.”
“The results obtained with one-third of the dose of PDGF-BB with the BioChaperone PDGF-BB spray pave the way for a cost-effective treatment in this disease affecting ten million people worldwide,” said Dr Gérard Soula, chairman & CEO of Adocia. “Cost of treatment is a key issue not only in emerging countries but also in the western countries.”
These clinical results will be presented in major scientific congresses on wound healing, at the European Wound Management Association in Vienna, Austria, on May 23-25, 2012 and at the World Union of Wound Healing Societies in Yokohama, Japan on September 2-6, 2012.
“We are now actively preparing a phase III trial which could be launched in the fourth quarter of 2012 in India and two phase III clinical trials in the United States and in Europe planned for the second half of 2013,” said Dr Olivier Soula, VP R&D director of Adocia. “The Indian study should be the last step before marketing the product in emerging countries.”