US AND EU CLINICAL DEVELOPMENT PLANS
Ovoca Bio plc is pleased to announce that its subsidiary IVIX has commenced the process of preparing an integrated Clinical Development Plan (“CDP”) for its investigational drug candidate, Libicore (BP-101), for both the US and EU regions with Biorasi LLC (“Biorasi”), 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.”
For further information:
Ovoca Bio plc
Kirill Golovanov (Chief Executive)
Tel +353 1 661 9819
Davy (Nominated Adviser, Euronext Growth Advisor and Broker)
John Frain / Daragh O'Reilly
Tel: +353 1 679 6363
About Ovoca Bio plc
Ovoca Bio plc's goal is to become a leader in the development and commercialization of novel product candidates for the treatment of female sexual dysfunctions. In 2018, Ovoca Bio acquired IVIX and its promising clinical stage asset, Libicore (BP-101), for female sexual dysfunction, an area of significant unmet medical need. The magnitude of demand for treatments for female sexual dysfunction has only recently been recognized, and Ovoca believes it has the potential to become a substantial pharmaceutical market.
IVIX, a Russian‐incorporated company, was formed in 2012 and since that time has sought to develop and subsequently commercialise a proprietary drug candidate, BP101 (known as "Libicore"), for the treatment of female sexual dysfunctions. Libicore is a novel synthetic peptide, administrated through a nasal spray. Clinical studies completed to-date have demonstrated statistically significant efficacy in the treatment of major forms of female sexual dysfunction. So far, IVIX has reached and completed Phase II clinical studies in Russia for Libicore. It now intends to complete the ongoing Phase III clinical trial for Libicore, following which it will seek approval for the marketing of Libicore in the Russian market, as well seek to expand its use internationally.
Biorasi is an award-winning contract research organization accelerating drug and device clinical development for life sciences companies around the world. Since 2002, Biorasi has achieved success in bringing innovative therapies to market by forming true partnerships with sponsors, and focusing on processes, methodologies, and technologies that move the industry forward. Biorasi is headquartered in Miami, Florida, and has regional offices around the globe.
Chief Marketing Officer, Biorasi