Drug Interactions in vitro for EP055: a Non-Hormonal Male Contraceptive

Project Summary The global contraceptives market was valued at $billion inand is expected to grow at a CAGR offromtoto reach an estimated value of $billion inThe contraceptive market consists of short term methods such as condoms and oral contraceptionlong term methods including implants and IUDsand permanent methods such as tubal ligations and vasectomiesEppin Pharmaandapos s product has a unique set of characteristicsnamely ease of usehigh efficacyreversibility and no side effectsthat differentiates it favorably from all the other male contraceptive competitorsAn important high impact driver of this market is the prevalence of unintended pregnanciesIn the US there aremillion unintended pregnancies annually through inconsistent or non use of contraceptionEppin Pharma will be competing in the short term contraception marketThe goal of EPPIN PHARMA INC is to develop a non hormonal male contraceptive drug that targets the protein EPPINwhich is present on the human sperm surfaceUnlike hormonal contraception which inhibits spermatogenesis our therapeutic agentEPis present in epididymal fluid and binds to EPPIN on the surface of sperminhibiting sperm motilityThe target EPPIN is only present in the malein testisepididymisand on spermthereby reducing non specific binding concernsThe Specific Aims of this SBIR proposal are designed to complement STTR phasedata and initiate metabolic and transporter studies of EPwhich are needed before first in human studies can beginIt is crucial to determine if EPwill have significant drug drug interaction before proceeding further because the male contraceptive would be taken by a healthy population of men or womenOur goal in this SBIR phase I application is to collect additional pharmacology data that will support and facilitate the completion of an IND application to the FDASpecific aimwill determine if EPis a substrateinhibitoror inducer of cytochrome PSpecific Aimwill determine if EPis a substrateor inhibitor of a transporterThis aim will evaluate transporters that are predominantly in the intestineliverkidneys and blood brain barrierSpecific aimwill analyze and document our drug manufacturing processscale up for production of EPto support future nonclinical and clinical studies Relevance to Public Health This research proposal is relevant to public health because it will develop a new male nonhormonal contraceptive that will enhance family planning throughout the world and give men and women additional contraceptive choicesCurrently men are limited in their options for contraception to condoms and vasectomyTherefore a non hormonal male contraceptive will fill an unmet need in contraceptionThis proposal is designed to develop a drug for male contraception that targets EPPIN and will initiate metabolic and transporter studies of EPwhich are needed before first in human studies can begin