Assessing inhibitor efficacy in vivo and developing a biomarker for use during early phase clinical trials

NIH RePORTER · NIH · P50 · $601,603 · view on reporter.nih.gov ↗

Abstract

Project 2 Mammalian sperm are stored in the epididymis in a dormant state; they are immotile and unable to fertilize the oocyte. Upon ejaculation, motility is activated via bicarbonate-induced stimulation of soluble adenylyl cyclase (sAC: ADCY10). Men and male mice with the sAC gene knocked out are infertile, and pharmacological inhibitors specific for sAC block in vitro fertilization and render male mice temporarily infertile. Thus, sAC is a nonhormonal target, genetically and pharmacologically validated to be essential for male fertility. The goal of the Weill Cornell Medicine Contraceptive Research Center (WCM-CRC) is to develop acutely acting sAC inhibitors into safe and effective nonhormonal, orally available, on-demand contraceptives which men take only when and as often as needed, shortly before sex. In this Contraception Translational Research Project, we will establish a second, non-rodent animal model for testing contraceptive efficacy; test the in vivo efficacy of optimized sAC inhibitors; and validate sperm motility as a pharmacodynamic biomarker of efficacy for use in early phase clinical trials of an on-demand male contraceptive. A goal of this Project, and the WCM-CRC, is to identify a lead candidate (along with backups) to progress into studies enabling an Investigational New Drug (IND) application as a novel oral, nonhormonal contraceptive for men.

Key facts

NIH application ID
10904994
Project number
5P50HD113015-02
Recipient
WEILL MEDICAL COLL OF CORNELL UNIV
Principal Investigator
JOCHEN BUCK
Activity code
P50
Funding institute
NIH
Fiscal year
2024
Award amount
$601,603
Award type
5
Project period
2023-08-10 → 2026-05-31