ORION BIOTECHNOLOGY SUCCESSFULLY COMPLETES PHASE I CLINICAL STUDY OF 0B-002H TOPICAL GEL FOR HIV PREVENTION
Ottawa, Canada, April 30, 2020 (GLOBE NEWSWIRE) — Orion Biotechnology Canada Ltd., a clinical stage pharmaceutical company focused on precision engineering small protein therapeutics, today announced successful completion of participant follow-up in their Phase 1 study of OB-002H which is an investigational candidate microbicide. The Phase 1 study was a first-in-man trial designed to evaluate the safety, acceptability, and pharmacokinetic profile of OB-002H gel which is being developed for a HIV prevention indication. The study design included open-label single-dose and multi-dose product administration to study participants followed by a randomised, double-blind, placebo-controlled multi-dose phase of product administration. The study enrolled a total of 30 healthy volunteers in Warsaw, Poland at the BioVirtus Phase 1 Research Site. Orion plans to submit the study data to the HIVR4P HIV prevention meeting which will be held in Cape Town South Africa in January 2021 (https://www.hivr4p.org/).“We are pleased with how quickly we were able to enroll this Phase I trial, and I want to congratulate the team at BioVirtus for completing patient follow-up under challenging conditions with the arrival in Poland of the SARS-CoV-2 global pandemic” stated Mark Groper, President and CEO of Orion Biotechnology. “We are delighted to have completed this important study and look forward to the next development phase of this novel therapeutic.”Dr. Ian McGowan, added, “Orion would like to thank the investigators, study participants and researchers for their participation in this study. Despite advances in the diagnosis and treatment of HIV infection, there remains a significant unmet need for HIV prevention products that women and men can use to protect themselves from HIV infection. A gel product that could be used in a pericoital fashion would be an important addition to the available options for HIV prevention. Successful completion of this study marks an important milestone towards this goal.” About Orion Biotechnology Canada, Ltd.Orion Biotechnology Canada Ltd, is a clinical stage biopharmaceutical company focused on the discovery and development of precision engineered small protein therapeutics – a promising new class of drugs designed to modulate immune response and deliver the next generation of immunotherapy treatment for cancer and other serious diseases. Leveraging its unique expertise in protein engineering and cell receptor pharmacology, as well as its proprietary drug discovery platform, Orion is pursuing a range of novel targets including chemokines and other G-Protein Coupled Receptors (GPCR’s). Orion’s lead candidate, OB-002, is a first-in-class chemokine analog and best in class CCR5 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 StatementsThis 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.Ross MacLeod
Orion Biotechnology Canada Ltd.