The proposed product is a fixed-dose combination (FDC) tablet of TDF / FTC / LNG / EE indicated for both the prevention of HIV and pregnancy. The product will be supplied as a 28-count blister compliance pack containing 21 tablets of the fixed-dose combination of TDF, FTC, LNG, and EE (a 3-week supply) plus 7 tablets of FTC and TDF (a 1-week supply).
This is the first-in-human clinical study to see if a single dose of an investigational enema made from a modified plant protein called Q-Griffithsin is safe, tolerated, and acceptable for use by healthy adults 18-45 years of age who practice receptive anal intercourse. GRFT is one of the most powerful, broad-spectrum antivirals ever tested and its activity is under study for potential therapeutic applications against several viral pathogens including HIV, herpes simplex virus type-2, human papillomavirus (HPV), and hepatitis C. For the purposes of this study GRFT has been genetically modified to produce a more stable compound less prone to oxidation, Q-GRFT
Silica hydrogel-based long-acting injectable delivering ARV and levonorgestrel for up to 6 months duration. Currently in preclinical development.
First-in-line, ultra-long-acting injectable MPT that offers durable and sustained protection from HIV transmission, high efficacy of contraception, increased user compliance, and the ability to be removed. It consists of a liquid MPT formulation utilizing excipients that form a biodegradable depot after subcutaneous injection (in-situ forming implant (ISFI)).
Our paramount innovation is use of digital light synthesis – a novel 3D printing process known as continuous liquid interface production (CLIP™) – for rapid, scalable, and cost-effective manufacturing of geometrically and mechanically tunable, rationally designed intravaginal rings as platforms for multi-drug delivery.
Multipurpose Vaginal pH Regulator (MVP-R™) with non-ARV (anti-retroviral) microbicide for the prevention of pregnancy, HIV, and other STIs.
A 90-day pod-type MPT IVR for pregnancy and HIV prevention that could reduce both the emergence of ARV-resistant HIV and the concern of potential increased risk of HIV transmission associated with use of progestin-only products.
A next generation MPT film platform for once a month intravaginal administration of 4′-Ethynyl-2-fluoro-2′-deoxyadenosine (EFdA) or the EFdA prodrug (EFdA-P) and a progestin (levonorgestrel (LNG) or etonogestrel (ENG)) to achieve the dual goal of preventing HIV infection and pregnancy.
An on-demand fast dissolve vaginal insert (FDI) MPT vaginal pH regulator (MVP-R™) for pregnancy and STI prevention.
Development of prototypes of long- and short-acting versions of an innovative female-controlled, non-hormonal copper vaginal contraceptive method that may also reduce risk for acquisition of sexually transmitted infections and will be suitable for Phase I human clinical testing.