OB-002 topical / Orion Biotech - LARVOL DELTA

Evaluation of the Safety, Acceptability, and Pharmacokinetic Profile of a Gel Formulation of OB-002 in Healthy Volunteers. (PubMed, AIDS Res Hum Retroviruses) - "OB-002 is an extremely potent CCR5 antagonist that has previously been shown to completely block transmission in a non-human primate model of HIV infection. Overall, the product had a positive acceptability profile, and most study participants would consider using the product for protection against HIV or pregnancy. Future studies are needed to assess the extended safety and acceptability of OB-002H gel in sexually active participants."

Clinical • Journal • PK/PD data • Human Immunodeficiency Virus • Infectious Disease

OB-002H Gel Administered Vaginally and Rectally in HIV-1 Seronegative Adults (clinicaltrials.gov) - P1; N=60; Completed; Sponsor: Orion Biotechnology Polska Sp. z o.o.

Clinical • New P1 trial • Human Immunodeficiency Virus • Infectious Disease

[VIRTUAL] Phase 1 evaluation of the safety, acceptability, and pharmacokinetic profile of an OB-002H gel (HIVR4P 2021) - "BACKGROUND: OB-002 is an extremely potent CCR5 antagonist that has previously been shown to completely block vaginal transmission of a SHIV virus (SF162P3) in a non-human primate model of HIV infection (Veazey R et al. OB-002H gel was safe and well tolerated with a good acceptability profile and high intentionality of future use. Future studies are needed to assess the extended safety and acceptability of the product in sexually active participants."

Clinical • Late-breaking abstract • P1 data • PK/PD data • Human Immunodeficiency Virus • Infectious Disease

Orion Biotechnology Successfully Completes Phase 1 Clinical Trial of a First-in-Class Precision Engineered Ligand Analog for HIV Prevention (GlobeNewswire) - P1, N=30; "Orion Biotechnology Canada Ltd....today announced the results of their Phase 1 study of OB-002H which is an investigational candidate microbicide for HIV prevention....The product was well tolerated...Product acceptability was also high with the majority of participants...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....'We look forward to exploring options for the further development of this exciting product.'"

P1 data • Human Immunodeficiency Virus