Adocia has begun Phase III development of its BioChaperone PDGF-BB spray product for the treatment of diabetic foot ulcers (DFUs). The European Medicines Agency (EMA) issued positive scientific advice for this programme.
Based on positive results of a Phase II trial in India, Adocia has filed a dossier for a Phase III trial there. The dossier is currently under review by the Drugs Controller General of India. The trial should permit Adocia to file a request for marketing authorisation in India and other emerging countries. The company is also preparing a clinical programme for marketing the product in Europe and the US.
In Europe, Adocia is focusing on the treatment of neuroischaemic DFUs. There is currently no approved treatment for this indication in Europe; however, according to Adocia, there is a medical need for this indication, which should facilitate the regulatory approval of a treatment for the disease. In order to validate the regulatory pathway for marketing application authorisation (MAA), Adocia has asked for scientific advice from the EMA. The EMA agreed that only one Phase III study conducted in Europe would be required for the MAA. In addition, the data from the Phase III trial in India would be admissible to the MAA.
The EMA advice also included agreement on the design and protocol features of the Phase III trial. The Phase III trial in Europe is designed to assess the efficacy of BioChaperone PDGF-BB compared with a placebo for the treatment of neuroischaemic DFUs. The trial is expected to be launched in mid 2014.
The company is currently preparing the submission of the clinical development plan for the FDA in the US.