Ovoca Bio PLC US and EU Clinical Development Plans (7071W)
April 23 2019 - 1:00AM
UK Regulatory
TIDMOVB
RNS Number : 7071W
Ovoca Bio PLC
23 April 2019
Ovoca Bio plc
("Ovoca" or the "Company")
US and EU Clinical Development PlanS
Ovoca Bio plc (LSE: OVB; ISE: OVXA) is pleased to announce that
its subsidiary IVIX LLC ("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 +7 495 916 6029
info@ovocabio.com
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.
About IVIX
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.
About Biorasi
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.
Contact:
Alexandre Mouravskiy
Chief Marketing Officer, Biorasi
amouravskiy@biorasi.com
1.786.888.1822
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END
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