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

EP055，一种非激素男性避孕药：IND支持研究

• 批准号: 10252385
• 负责人: MICHAEL GENE ORAND
• 金额: $ 69.26万
• 依托单位: EPPIN PHARMA, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-19 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10252385
• 关键词: ABCG2 gene; Acute; Binding; Blood - brain barrier anatomy; Canis familiaris; Cardiovascular system; Categories; Characteristics; Chronic; Clinical Research; Clinical Trials; Conscious; Contraceptive Agents; Contraceptive methods; Cytochrome P450; Data; Developed Countries; Development; Dose; Electrocardiogram; Epididymis; Evaluation; Family Planning; Feedback; Formulation; Future; Goals; Grant; Heart Rate; Human; Implant; Intestines; Kidney; Kilogram; Lead; Life; Liquid substance; Liver; Lung; Male Condoms; Male Contraceptive Agents; Methods; Oral; Oral Contraceptives; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacology; Pharmacology and Toxicology; Phase; Phase I Clinical Trials; Prevalence; Process; Production; Protease Inhibitor; Proteins; Public Health; Rattus; Recovery; Research Proposals; Safety; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Source; Sperm Motility; Spermatogenesis; Surface; Technology; Testis; Therapeutic; Therapeutic Agents; Toxic effect; Toxicology; Tubal Ligation; United States; Vasectomy; Woman; body system; condoms; contraceptive target; design; drug candidate; electric impedance; hormonal contraception; implantable device; improved; in vivo; inhibitor/antagonist; male; manufacturing process; meetings; men; neurobehavioral test; phase 1 study; pill; preclinical study; pressure; process optimization; programs; public health research; respiratory; scale up; side effect; sperm cell; telemetering; unintended pregnancy

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.

2018年，全球避孕用品市场的价值为240亿美元，预计将以每年10亿美元的速度增长