Adocia reports positive phase II clinical results for the treatment of diabetic foot ulcer
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(R) 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(R).
“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. “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.”
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