LONDON (ShareCast) - (Sharecast News) - Ovoca Bio announced on Tuesday that its subsidiary IVIX has begun the process of preparing an integrated clinical development plan for its investigational drug candidate, 'Libicore' (BP-101), for both the US and EU regions with US-based contract research organisation Biorasi.
The AIM-traded firm said Biorasi's medical and scientific affairs team would lead the preparation of the integrated plan for inclusion in the clinical section of the submission dossiers under the scientific advice procedure at the German Federal Institute for Drugs and Medical Devices (BfArM), and for a pre-Investigational New Drug (IND) meeting process with the US FDA.

During consultations with those regulatory agencies, Ovoca said it was planned to review pre-clinical and clinical data, and manufacturing operations for Libicore, and to gather the agencies' comments on the proposed development program and study design.

It would be an "important step" for the programme to confirm Libicore development plans that would be acceptable in Europe and the US, the Ovoca board said in its statement.

"Preparation of a smart clinical development program for our compound which is compliant with both US and EU regulatory requirements, is one of the most critical components of our strategy to pursue these attractive markets," said Biorasi general director Daniil Nemenov.

"We are pleased to undertake this work with Biorasi, considering their extensive experience in this area."

Boris Reznik, chairman of Biorasi, added that the company was "very excited" to begin the project with Ovoca and IVIX.

"Their BP-101 drug candidate has shown promising performance in clinical trials so far, and we believe there is high potential in bringing it over to the EU and US markets," Reznik explained.

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