The global contraceptives market was valued at $16.0 billion in 2011 and is expected to grow at a CAGR of 5.9% from 2013 to 2018, to reach an estimated value of $23.3 billion in 2018. The contraceptive market consists of short-term methods such as condoms and oral contraception, long-term methods including implants and IUDs, and permanent methods such as tubal ligations and vasectomies. Eppin Pharma's product has a unique set of characteristics, namely ease-of use, high efficacy, reversibility and no 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 through inconsistent or non-use of contraception. Eppin Pharma will be competing in the short-term contraception market. The goal of EPPIN PHARMA INC is to develop a non-hormonal male contraceptive drug that targets the protein EPPIN, which is present on the human sperm surface. Unlike hormonal contraception which inhibits spermatogenesis our therapeutic agent, EP055, is present in epididymal fluid and binds to EPPIN on the surface of sperm, inhibiting sperm motility. The target EPPIN is only present in the male; in testis, epididymis, and on sperm, thereby reducing non-specific binding concerns.
The Specific Aims of this SBIR proposal are designed to complement STTR phase 2 data and initiate metabolic and transporter studies of EP055, which are needed before first-in-human studies can begin. It is crucial to determine if EP055 will have significant drug-drug interaction before proceeding further because the male contraceptive would be taken by a healthy population of men or women. Our 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 FDA.
Specific aim #1 will determine if EP055 is a substrate, inhibitor, or inducer of cytochrome P450.
Specific Aim #2 will determine if EP055 is a substrate, or inhibitor of a transporter.
This aim will evaluate transporters that are predominantly in the intestine, liver, kidneys and blood brain barrier.
Specific aim 3 will analyze and document our drug manufacturing process; scale up for production of EP055 to support future nonclinical and clinical studies.
This research proposal is relevant to public health because it will develop a new male non- hormonal contraceptive that will enhance family planning throughout the world and give men and women additional contraceptive choices. Currently men are limited in their options for contraception to condoms and vasectomy. Therefore a non-hormonal male contraceptive will fill an unmet need in contraception. This proposal is designed to develop a drug for male contraception that targets EPPIN and will initiate metabolic and transporter studies of EP055, which are needed before first-in-human studies can begin.
