Date: 2013-03-18
Type of information: Initiation of development program
phase: 3
Announcement: announcement of the phase 3 development programme
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: Europe
Trial details:
Latest
news: * On March 18, 2013, Adocia, a biotechnology company specialized in the development of ‘best-in-class’ medicines from already approved therapeutic proteins has announced the phase III development program of its product, BioChaperone® PDGF-BB for the treatment of diabetic foot ulcer (DFU). The European Medicines Agency (EMA) issued positive scientific advice for this program. 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. Meanwhile, Adocia is actively preparing a clinical program for marketing the product in Europe and the United States of America.
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.
The company is also preparing the submission of the clinical development plan for the FDA.
