Development of Multipurpose Technologies Products for Pregnancy and STI Prevention; update on polyphenylene carboxymethylene MPT gel development.

We present the case for developing simple non-hormonal vaginal products that women can use when needed, ideally products that are multipurpose and offer both contraception and sexually transmitted disease protection. Gel-based vaginal products are particularly well-suited for this purpose. Gels are easy to use, highly acceptable to many women, and can be safely formulated to enhance natural vaginal defenses against infection. However, the development of a new chemical entity for this application faces significant technical and regulatory hurdles. These challenges and our solutions are described for polyphenylene carboxymethylene (PPCM), a novel topical drug in a vaginal gel nearing human clinical trials. We have advanced PPCM from benchtop to IND-enabling studies and provide a brief description of the complex development process. We also describe a simple lab assay which can be used as a biomarker for contraceptive activity to enable pharmacodynamic studies in vaginal contraceptive development, both preclinically and in early human clinical trials. PMID: 32469052 [PubMed - as supplied by publisher]
Source: Biology of Reproduction - Category: Reproduction Medicine Authors: Tags: Biol Reprod Source Type: research