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

2018年全球避孕药市场价值240亿美元，预计将以 2019年至2027年的复合年增长率为6.9%。避孕药市场由短期方法组成 如避孕套、口服避孕药、贴片和戒指、包括植入物在内的长期方法 和宫内节育器，以及永久性的方法，如输卵管结扎和输精管结扎术。全球避孕套 预计2018年市场收入将达到120亿美元，并预计将以 2019年至2024年期间增长9%。2018年避孕套在美国的销售额为2亿美元 2017-2020年间，年均增长率为3.5%。目前还没有商业上可用的 涉及口服药丸的非激素男性避孕技术类别的产品 和/或将在短期市场上竞争的植入式设备。Eppin制药公司 药物将提供男用避孕套的重要药物替代品，并应要求 在避孕药具市场占有相当大的份额。一旦上市，这种新的雄性 避孕技术有可能颠覆传统的男性避孕措施 避孕套市场以及一般的避孕药市场。Eppin Pharma的市场评论 新的男性避孕技术进入者可以可行地捕获8%-10%的 传统的短期男性避孕药市场，至少5.5亿美元。Eppin制药公司 产品有一套独特的特点，即易用性、可逆性和最小的副作用-- 使其有别于所有其他男性避孕药竞争者的效果。一个 这一市场的重要高影响驱动因素是意外怀孕的盛行；在 美国每年有310万例意外怀孕是由于不一致或没有使用 避孕。Eppin Pharma是一家新兴制药公司，专注于 开发一种安全的、非激素的男性避孕药，可以口服。这个 该公司的候选避孕产品是一种与Eppin结合的小型有机化合物 (附睾酶抑制物)，人类精子表面的一种蛋白质，导致 精子活力。本SBIR第二阶段提案的具体目标旨在 SBIR第一阶段数据，并证明我们的先导化合物EP055是安全的，可以用于 作为针对Eppin的口服男性避孕药的第一阶段临床试验。具体目标是： 1)安全药理学；此目标旨在评估EP055导致 对生命至关重要的器官系统的影响：中枢神经系统、呼吸系统和心血管系统。2) 毒理学；重复剂量GLP毒理学研究。3)生产2公斤EP055。

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.