Biosyn Inc announced that enrollment has been initiated for a Phase I clinical trial for the investigational drug candidate, UC-781, as a microbicide for the prevention of sexually transmitted HIV. UC-781 is an HIV non-nucleoside reverse transcriptase inhibitor (NNRTI) that has shown in vitro to be very active specifically against HIV-1.
This first clinical trial of UC-781 is a single-center, Phase I, placebo-controlled, closed-label, randomized study to evaluate the safety and acceptability of daily intravaginal dosing of the product among 48 healthy sexually abstinent women. Participants will be administering 3.5 ml of 0.1%, 0.25%, 1.0% UC-781 gel, or placebo gel once daily for a total of six consecutive days with clinical evaluations to take place after the first and sixth applications. The Contraceptive Research and Development Program (CONRAD) is conducting the study in behalf of Biosyn at Eastern Virginia Medical School in Norfolk, VA with funds from its Global Microbicide Program.
Future clinical trials will investigate the potential safety and efficacy of UC-781 in preventing the transmission of HIV among sexually active women. Also in development at Biosyn are other STD prevention product candidates including 1.0% C31G vaginal gel, entering Phase III clinical trials, and cyanovirin-N (CV-N), an HIV fusion inhibitor, in preclinical development.