Orion Biotechnology to Initiate Clinical Trials of Its Innovative Microbicide Gel for HIV Prevention

OTTAWA, Ontario, Sept. 12, 2019 /PRNewswire/ -- Orion Biotechnology Canada Ltd. today announced that the Polish National Regulatory Agency and Local Ethics Committee have given approval for the OB-002H-101 Phase 1 safety and acceptability study of OB-002H gel to start screening and enrollment. The OB-002H gel is a topical formulation of OB-002 (5P12-RANTES), a novel chemokine analogue that binds to the CCR5 receptors in order to prevent HIV infection. OB-002 is best-in-class in terms of in vitro potency and has previously been shown to completely prevent SHIV infection in a non-human primate (NHP) model of HIV infection (Veazey R et al. Journal of Infectious Diseases 2009). The OB-002H-101 study will enroll 30 healthy volunteers who will receive either single or multiple vaginal or rectal doses of the gel product. The study will evaluate the safety, acceptability, and pharmacokinetic (PK) profile of the gel and will be conducted at a Phase 1 research unit in Warsaw, Poland. Preliminary data from the study are anticipated in Q2 2020.

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"Orion Biotechnology is very excited to move our OB-002H gel into the clinic," said Dr. Ian McGowan, Chief Medical Officer for Orion Biotechnology. "Despite increasing access to oral pre-exposure prophylaxis with Truvada®, we believe there is an important role for HIV prevention products that can be used in a pericoital fashion."

Mark Groper, President and CEO of Orion Biotechnology added; "It is unacceptable that we are still seeing 1.8 million new HIV infections each year and there is a compelling need to expand the HIV prevention portfolio so that men and women have more options to protect themselves from HIV infection. OB-002 has been shown to be safe and 100% protective in an NHP challenge model which makes it an ideal microbicide candidate."

Professor Gita Ramjee from the Aurum Institute, Johannesburg, South Africa and a member of the OB-002H-101 Safety Monitoring Committee commented; "Young women in South Africa need more HIV prevention options and I look forward to working with the team at Orion Biotechnology to evaluate results from their Phase 1 study of the OB-002H gel."

About Orion Biotechnology Canada, Ltd.

Orion Biotechnology Canada Ltd, is a privately held pharmaceutical company leveraging advanced receptor pharmacology to develop novel therapies for serious chronic illnesses and life-threatening diseases. Since 2017, Orion Biotechnology has been developing a robust pipeline of first-in-class chemokine analogue drug candidates, including our lead candidate, OB-002 – a CCR5 receptor antagonist. Our close ties to diverse institutions and experts around the globe, as well as our proprietary drug discovery platform, continue to stimulate the rapid discovery of promising new treatments. Learn more at www.orionbiotechnology.com.

Forward-Looking Statements

This press release contains forward-looking information, which reflects Orion's current expectations regarding future events. Forward-looking information is based on a number of assumptions and is subject to a number of risks and uncertainties, many of which are beyond Orion's control, that could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking information. These forward-looking statements are made as of the date of this press release and, except as expressly required by applicable law, Orion assumes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contact: Ross MacLeod
Orion Biotechnology Canada Ltd
Phone: +1.343.291.1032
info@orionbiotechnology.com

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