Adocia (NYSE Euronext Paris: FR0011184241 - ADOC), a biotechnology company specialized in the development of ‘best-in-class’ medicines from already approved therapeutic proteins announces today the phase III development program of its product, BioChaperone(R) PDGF-BB for the treatment of diabetic foot ulcer (DFU). The European Medicines Agency (EMA) issued positive scientific advice for this program.
Adocia has developed a unique formulation, a BioChaperone PDGF spray for the treatment of DFU. Based on the positive results of the phase II clinical trial in India, Adocia has filed a dossier for a phase III clinical trial there. This dossier is currently under review by the DCGI (Drugs Controller General of India). The trial should permit Adocia to file a request for marketing authorization in India and other emerging countries.
Adocia is also actively preparing a clinical program for marketing the product in Europe and the United States of America.
In Europe, Adocia is focusing on the treatment of neuroischemic DFU which is the most frequent form of the disease; affecting 60 per cent of patients. It is the most difficult to heal with a high rate of amputation. There is currently no approved treatment for neuroischemic DFU. 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 the Marketing Authorization Application (MAA) Adocia has asked for scientific advice from the EMA.
The EMA agrees that only one phase III study conducted in Europe would be required for the MAA. In addition, the clinical 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 pivotal phase III clinical trial in Europe is designed to assess the efficacy of BioChaperone PDGF-BB compared to a placebo for the treatment of neuroischemic DFU. The trial is expected to be launched in mid 2014.
“This scientific advice from the EMA which validates our clinical program in Europe is an important milestone. We are now preparing the submission of the clinical development plan for the FDA in the USA,” said Olivier Soula, director of R&D and deputy general manager, Adocia.
“This positive advice was critical in order to move forward in our discussions with potential partners as it helps to define budget and milestones until commercialization,” said Gerard Soula, president & CEO of Adocia.
Adocia has developed a unique formulation, a BioChaperone PDGF spray for the treatment of DFU. Based on the positive results of the phase II clinical trial in India, Adocia has filed a dossier for a phase III clinical trial there. This dossier is currently under review by the DCGI (Drugs Controller General of India). The trial should permit Adocia to file a request for marketing authorization in India and other emerging countries.
Adocia is also actively preparing a clinical program for marketing the product in Europe and the United States of America.
In Europe, Adocia is focusing on the treatment of neuroischemic DFU which is the most frequent form of the disease; affecting 60 per cent of patients. It is the most difficult to heal with a high rate of amputation. There is currently no approved treatment for neuroischemic DFU. 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 the Marketing Authorization Application (MAA) Adocia has asked for scientific advice from the EMA.
The EMA agrees that only one phase III study conducted in Europe would be required for the MAA. In addition, the clinical 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 pivotal phase III clinical trial in Europe is designed to assess the efficacy of BioChaperone PDGF-BB compared to a placebo for the treatment of neuroischemic DFU. The trial is expected to be launched in mid 2014.
“This scientific advice from the EMA which validates our clinical program in Europe is an important milestone. We are now preparing the submission of the clinical development plan for the FDA in the USA,” said Olivier Soula, director of R&D and deputy general manager, Adocia.
“This positive advice was critical in order to move forward in our discussions with potential partners as it helps to define budget and milestones until commercialization,” said Gerard Soula, president & CEO of Adocia.
