EP055, a non-hormonal male contraceptive:IND-enabling studies

The global contraceptives market was valued at $24BN in 2018 and is expected to grow at a CAGR of 6.9% from 2019 to 2027. The contraceptive market consists of short-term methods such as condoms, oral contraceptives, patches and rings, long-term methods including implants and IUDs, and permanent methods such as tubal ligations and vasectomies. The global condom market was expected to see $12BN in revenue in 2018 and is projected to grow at a CAGR of 9% over the period 2019-2024. Condoms accounted for $200MM in the United States in 2018 growing at a CAGR of 3.5% from 2017-2020. There are currently no commercially available products in the category of non-hormonal male contraceptive technologies involving oral pills and/or implantable devices which would compete in the short-term market. Eppin Pharma's drug will provide a significant pharmaceutical alternative to male condoms and should command a significant share of the contraceptive market. Once commercially available, this new male contraceptive technology has the potential to be disruptive to the traditional male contraceptive condom market as well as the contraceptive market generally. Eppin Pharma's market review projects that new male contraceptive technology entrants can feasibly capture 8-10% of the traditional short-term male contraceptive market which is at least $550MM. Eppin Pharma's product has a unique set of characteristics, namely ease-of use, reversibility and minimal side- effects that differentiates it favorably from all the other male contraceptive competitors. An important high impact driver of this market is the prevalence of unintended pregnancies; in the US there are 3.1 million unintended pregnancies annually due to inconsistent or non-use of contraception. Eppin Pharma is an emerging pharmaceutical company focused on the development of a safe, non-hormonal male contraceptive that can be taken orally. The company's contraceptive product candidate is a small organic compound that binds to EPPIN (epididymal protease inhibitor), a protein on the surface of human sperm, resulting in the loss of sperm motility. The Specific Aims of this SBIR Phase 2 proposal are designed to build on SBIR phase 1 data and demonstrate that our lead compound, EP055, is safe and ready for a phase 1 clinical trial as an oral male contraceptive that targets EPPIN. The Specific aims are: 1) Safety pharmacology; this aim is intended to evaluate the potential for EP055 to cause effects on organ systems acutely critical for life: CNS, Respiratory and Cardiovascular. 2) Toxicology; repeat-dose GLP toxicology studies. 3) Manufacture of 2kg of EP055.