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.”