Novel non-narcotic analgesic for acute and chronic pain

用于急性和慢性疼痛的新型非麻醉镇痛药

• 批准号: 10819946
• 负责人: Robert Naismith
• 金额: $ 39.95万
• 依托单位: SOUTH RAMPART PHARMA, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-30 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10819946
• 关键词: Acetaminophen; Acute Pain; Advanced Development; Agreement; Aspirin; Biological Availability; Businesses; Clinical; Data; Development; Dose Limiting; Drug Kinetics; Funding; Goals; Grant; Health; Hepatotoxicity; Ibuprofen; Lead; Leadership; Mediation; Non-Steroidal Anti-Inflammatory Agents; Opioid; Outcome; Overdose; Pain; Pain management; Patients; Pharmacologic Substance; Phase; Readiness; Risk; Role; Safety; Schedule; Secure; Series; Testing; Therapeutic Trials; acetaminophen-induced liver injury; addiction; chronic pain; commercialization; commercialization readiness; cost; cost estimate; design; expectation; innovation; interest; meetings; nephrotoxicity; non-opioid analgesic; novel; phase I trial; phase II trial; phase III trial; product development; programs; prospective

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.

项目总结