Ovoca Bio PLC – US and EU Clinical Development Plans

Ovoca Bio plc (LSE: OVB; ISE: OVXA) is pleased to announce that its subsidiary IVIX LLC  has commenced 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 Biorasi LLC, an experienced US-based contract research organization.

The Medical and Scientific Affairs team from Biorasi will lead the preparation of the integrated CDP 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-IND (Investigational New Drug) meeting process with the US FDA. During consultations with these regulatory agencies, it is planned to review pre-clinical and clinical data, and manufacturing operations for BP-101, and to gather the agencies’ comments on the proposed development program and study design. It will be an important step for the program to confirm BP-101 development plans that will be acceptable in Europe and the US.

Daniil Nemenov, General Director of IVIX, commented: “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. We are pleased to undertake this work with Biorasi, considering their extensive experience in this area.”

Boris Reznik, chairman of Biorasi added: “We are very excited to begin this project with Ovoca/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.”