Polyphenylene carboxymethylene sodium salt (PPCM) is being developed by Yaso Therapeutics as a woman-controlled, on-demand vaginal contraceptive gel (PPCM-GEL) with a unique, non-cytotoxic mechanism that triggers premature acrosomal loss of sperm, rendering them incapable of fertilization. Since PPCM alsobinds highly conserved glycosaminoglycans, this novel gel has additional potential to function as amultipurpose prevention technology (MPT) that protects against important bacterial and viral sexuallytransmitted infections (STIs). Under this grant we propose to complete one last packaging compatibility andstability study of PPCM-GEL, complete writing the IND per eCTD and FDA guidelines, and have a regulatoryconsulting firm electronically submit the IND to FDA.With the support of prior NIAID and NICHD grants (R42AI069659, R43/44AI084225,5R44HD092206), we haveadvanced PPCM through preclinical evaluation and have successfully formulated a mucoadhesive, non-irritating vaginal gel that is ready for clinical evaluation. The mechanism of action on sperm has enabled us toconduct pre-clinical studies using a commercially available sperm quality biomarker, hyaluronan binding assay(HBA®) to assess potential contraceptive activity. In pre-clinical testing, we have also demonstrated potentactivity against Neisseria gonorrhoeae, herpes simplex virus, and HIV. PPCM-GEL is formulated for non-systemic topical use, is non-hormonal, and has potential to be one of the first successful MPT products withcontraceptive and broad STI/HIV prevention efficacies. The prevalence of unplanned pregnancy and STIsamong women in all economic, social, and cultural circumstances has remained high despite existingprevention options. There is a long-standing paucity of available on-demand and nonhormonal broad-spectrumprevention options. Availability of a dual-purpose product for contraception and STI/HIV prevention will armpeople with an important option for reproductive health.
Public Health Relevance Statement: NARRATIVE
Yaso Therapeutics is developing PPCM-GEL as a contraceptive MPT. Successful completion of this project
will result in an IND submission that allows us to conduct, in collaboration with the University of Pittsburgh, a
First-In-Human clinical trial. PPCM-GEL is a pleasing, non-hormonal, single pharmaceutical contraceptive
vaginal gel with anti-infective activity against both bacterial and viral sexually transmitted diseases. If
successful, PPCM-GEL could provide a new contraceptive which will have a positive impact on the global
numbers of unplanned pregnancies and sexually transmitted infections.
Project Terms:
