Novel non-narcotic analgesic for acute and chronic pain

项目摘要 South Rampart Pharma（SRP）是一家早期临床阶段的公司，专注于开发SRP-001， 非阿片类药物，用于治疗中度至重度急性和慢性疼痛，无剂量限制性肝毒性 对乙酰氨基酚和非甾体抗炎药的肾毒性，以及阿片类药物的滥用和成瘾潜力。SRP-001是 目前处于I期试验阶段，中期数据支持安全性和可接受的生物利用度的预期， 药代动力学SRP目前正在进行A轮融资，以资助计划开始的第二阶段 2023年下半年。 SRP-001的进一步开发将需要第三方投资者的支持，以提供概念验证功效 2期试验中的数据。这将是一个迫切需要与一个主要的制药或消费者合作 健康公司完成关键的3期试验和商业化。基于疼痛的历史数据 治疗试验，3期项目的估计成本为1.5亿美元-这一数字是不可能达到的， 战略伙伴关系在提交给PAR-23-069（HEAL商业化）的商业就绪项目中 准备（CRP）计划：嵌入式企业家为小企业在疼痛管理），SRP建议 以50%的努力聘用一名首席财务官，以推行积极的合作伙伴参与计划，确保合作伙伴关系，以支持 3期试验和商业化。 SRP提出了两个与PAR-23-069概述的两项所需活动相一致的目标： 目标1。以50%的努力雇佣一名业务开发专家担任公司领导职务。 预期结果： 1. CFO在项目的第2个月雇用了50%的工作量。 目标2.执行合作计划。 预期结果： 1.与200-300名潜在投资者和潜在合作伙伴进行初步接触， 疼痛和中枢神经系统的创新在第一年结束。 2.到第一年年底，与50-75名感兴趣的潜在客户会面。 3.允许20-30名有兴趣进一步讨论的潜在客户进入数据室。 4.与前景的更广泛的团队进行额外的会议，并与10-15名前景进行谈判 直到第二年。 5.与2-5家主要投资者达成协议，在18个月前完成A轮融资， 在第二年年底前与一家大型制药公司达成合作协议。

PROJECT SUMMARY South Rampart Pharma (SRP) is an early clinical-stage company focused on developing SRP-001, a novel non-opioid designed to treat moderate-to-severe acute and chronic pain without the dose-limiting hepatotoxicity of acetaminophen and nephrotoxicity of NSAIDs, and the misuse and addictive potential of opioids. SRP-001 is currently in Phase 1 trials where interim data support the expectation of safety and acceptable bioavailability and pharmacokinetics. SRP is currently conducting a Series A round to fund a planned Phase 2 scheduled to begin in H2 2023. Further development of SRP-001 will require third-party investor support to deliver proof-of-concept efficacy data in a Phase 2 trial. This will be followed by a critical need to partner with a major pharmaceutical or consumer health company to complete pivotal Phase 3 trials and commercialization. Based on historical data for pain therapeutics trials, the estimated cost of a Phase 3 program is $150M—a figure that is not attainable without a strategic partnership. In this Commercial Readiness Project submitted to PAR-23-069 (HEAL Commercialization Readiness (CRP) Program: Embedded Entrepreneurs for Small Business in Pain Management), SRP proposes to hire a CFO at 50% effort to pursue an aggressive partner engagement plan to secure a partnership to support Phase 3 trials and commercialization. SRP proposes two aligned aims with the two required activities outlined by PAR-23-069: Aim 1. Hire a business development expert in a company leadership role at 50% effort. Expected Outcome: 1. CFO hired for 50% effort by month 2 of the project. Aim 2. Execute a partnering plan. Expected Outcomes: 1. Initial contact with 200-300 prospective investors and potential partners with a specific interest in pain and CNS innovation by the end of Year 1. 2. Meetings with 50-75 interested prospects by the end of Year 1. 3. Data room access granted to 20-30 prospects interested in further discussions. 4. Additional meetings with the prospect’s broader team and negotiations with 10-15 prospects through Year 2. 5. Agreements secured with 2-5 lead investors, closing out Series A financing by Month 18, and securing a partnership agreement with a major pharmaceutical company by the end of Year 2.