Ottawa, Canada January 27, 2021: Orion Biotechnology Canada Ltd., a clinical stage pharmaceutical company focused on precision engineering small protein therapeutics, today announced that they will be presenting the results of their Phase 1 study of OB-002H at the HIVR4P virtual meeting (https://www.hivr4p.org/).
The OB-002H-101 Phase 1 study was a first-in-man trial designed to evaluate the safety, acceptability, and pharmacokinetic profile of the OB-002H gel which is being developed for a HIV prevention indication. OB-002 is a CCR5 inhibitor with best-in-class in vitro potency and is being evaluated in other indications including oncology and COVID-19. The study was conducted at the BioVirtus Research Site, Józefów, Poland and enrolled 30 healthy volunteers. Stage 1 was an open-label single-dose vaginal or rectal application of the OB-002H gel in 12 participants. Stage 2 was a multiple-dose vaginal application, with an initial open-label application of OB-002H gel in three participants, followed by a randomised, double-blind, placebo-controlled exposure during which 15 study participants received five sequential daily vaginal exposures to OB-002H gel or placebo.
The OB-002H gel was safe and well tolerated. Genital adverse events were Grade 1 or Grade 2 and transient. There was no evidence of systemic absorption of OB-002. Overall, the product had a positive acceptability profile, and when questioned, the majority of study participants stated that they would use the product for protection against HIV or pregnancy if the gel was subsequently licensed for these indications.
Dr. Ian McGowan, Chief Medical Officer at Orion Biotechnology stated, “We are delighted to have the opportunity to present our Phase 1 data for the OB-002H gel at the HIVR4P meeting. There remains a significant unmet need for HIV prevention products that women and men can use to protect themselves from HIV infection. In the OB-002H-101 Phase 1 study we showed that the gel was both safe and acceptable and most importantly that the majority of participants would consider using this type of product for HIV prevention. Having a gel product that could be used in a pericoital fashion would be a very important addition to the range of options available for HIV prevention.”
“I am delighted by the results from the OB-002H-101 Phase 1 study and we clearly need to move this innovative product into later stage development as quickly as possible” stated Mark Groper, President and CEO of Orion Biotechnology. “We are currently in discussion with a number of potential partners who would be interested in working with us on this exciting project.”