Today Auritec Pharmaceuticals received an IND approval to perform a 7-day open-label first-in-human of intravaginal IVR (IVR) delivery of the approved antiretroviral agents tenofovir disoproxil fumarate (TDF), emtricitabine (FTC) and mararviroc (MVC). The first primary objective of this Pre-Phase 1 study is to evaluate the safety of the “Single IVR (TDF alone), Dual IVR (TDF-FTC combination) and Triple IVR (TDF-FTC-MVC combination). The second objective of this pre-Phase 1 study is to evaluate the pharmacokinetics of the drugs by measuring plasma, cervicovaginal lavage, and cervicovaginal secretion concentrations of each drug in healthy women.
The diseases targeted by this proposal affect millions of patients in the developed world and represent a competitive multimillion dollar industry. At the beginning of 2013, worldwide, over half of all adults living with HIV were women. Our formulation offering the flexibility of monthly IVRs and potentially increased efficacy, offers significant advantages over the competitors for large numbers of patients. We therefore believe its impact to be high.
The long-term goal of this program is to empower women to protect themselves from HIV with methods that deliver sustained release combination antiretroviral therapy (cART) at the site of entry. IVRs provide a unique and promising system capable of delivering multiple combinations of cART at sustained, safe, yet potent concentrations over long durations, and cART IVRs could potentially block viral reproduction in the vaginal tissues while enabling a female-controlled method of intervention that can be used by women worldwide.