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.”