OTTAWA, Canada, Oct. 15, 2020 (GLOBE NEWSWIRE) -- Orion Biotechnology Canada Ltd., a clinical stage pharmaceutical company focused on precision engineering GPCR-targeted therapeutics, today announced the results of their Phase 1 study of OB-002H which is an investigational candidate microbicide for HIV prevention.
The Phase 1 study was a first-in-man trial designed to evaluate the safety, acceptability, and pharmacokinetic profile of OB-002H gel. OB-002, a highly potent chemokine analog of CCL5 (a ligand for the CCR5 HIV co-receptor), has previously been shown to be completely protective in a non-human primate model of vaginal HIV transmission (Veazey R et al. JID 2009). The Phase 1 study design included open-label single-dose (vaginal and rectal) and multi-dose product (vaginal) administration of OB-002H gel to study participants followed by a randomised, double-blind, placebo-controlled multi-dose (vaginal) phase of product administration. During the multi-dose phase of the study, participants received study product once daily for five days. The study enrolled a total of 30 healthy volunteers in Warsaw, Poland at the BioVirtus Phase 1 Research Site. The product was well tolerated, and product-related genital adverse events were mild (Grade 1) or moderate (Grade 2) and transient. Product acceptability was also high with the majority of participants expressing satisfaction with the product and the intent to use an OB-002H gel for prevention of HIV infection if the gel was available. There was no evidence of systemic absorption of OB-002 following single or multiple dose administration.
“The successful completion of this Phase I trial is an important milestone for Orion Biotechnology, and I want to congratulate the team at BioVirtus for finishing this study despite the challenges of conducting clinical research during the COVID-19 pandemic” stated Mark Groper, President and CEO of Orion Biotechnology.
Dr. Ian McGowan, Chief Medical Officer at Orion Biotechnology added, “Orion would like to thank the study participants, investigators, 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 demonstration of the safety and acceptability of OB-002H in this Phase 1 study marks an important first step towards this goal. We look forward to exploring options for the further development of this exciting product.”
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 class of drugs designed to modulate immune response and deliver the next generation of immunotherapy treatment for cancer and other serious diseases. Leveraging its proprietary drug discovery platform to facilitate rapid and low-cost development of its molecules, Orion is pursuing a range of novel targets including chemokine and other G-Protein Coupled Receptors (GPCR’s). Orion’s lead candidate, OB-002, is a first-in-class chemokine analogue 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 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.