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Testing a male oral contraceptive targeting Eppin

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42HD084077-02
Agency Tracking Number: R42HD084077
Amount: $1,832,621.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: NICHD
Solicitation Number: PA16-303
Timeline
Solicitation Year: 2016
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-06-15
Award End Date (Contract End Date): 2020-05-31
Small Business Information
3909 WINDY HILL RD
Chapel Hill, NC 27514-9611
United States
DUNS: 079308366
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 MICHAEL ORAND
 (919) 608-2984
 morand@eppin.com
Business Contact
 MICHAEL ORAND
Phone: (919) 608-2984
Email: morand@eppin.com
Research Institution
 OREGON HEALTH & SCIENCE UNIVERSITY
 
3181 SW SAM JACKSON PK RD
PORTLAND, OR 97239-3098
United States

 Nonprofit college or university
Abstract

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 USthere 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 nonhormonal 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 spermThe target EPPIN is only present in the malein testisepididymisand on spermthereby reducing non specific binding concernsThe Specific Aims of this STTR Phaseproposal are designed to build on STTR phasedata and formulate our lead compoundEPas an oral male contraceptive that targets EPPINOur goal in this STTR phase II application is to collect sufficient pharmacology data to conduct a pre IND meeting with the FDASpecific aimwill scale up production of purified EPto support additional preclinical studies and optimize AlphaScreen assays for formulation productsSpecific aimwill complete formulation studies with EPand create a test batch of tablets for preclinical pharmacology studiesSpecific aimwill conduct a monkey contraception fertility study for proof of principleSpecific aimwill conduct oral pharmacokinetics studies in rats and monkeysusing oral gavage in ratsoral dosing of tablets in monkeys and conduct dose range studies for PK PD assessment 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 vasectomyThereforea non hormonal male contraceptive will fill an unmet need in contraceptionThe proposal is designed to develop a drug for male contraception that targets EPPINThe proposal will provide formulation studiesa monkey contraception study for proof of principle and oral pharmacokinetics studies in rats and monkeys

* Information listed above is at the time of submission. *

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