South Rampart Pharma Broadens Global Patent Portfolio with EU Endorsement for FDA Fast-Tracked Pain Relief SRP-001
South Rampart Pharma, a clinical-stage life science company focused on innovative pain treatments, has expanded its global patent portfolio with the approval of European Patent No. 3672938 by the European Patent Office (EPO), effective November 1, 2023. This patent will apply to all Unified Patent Court-participating and non-participating European Unitary member states.
The patent, titled “Compositions and methods for ameliorating pain,” covers methods and compositions for a library of novel non-opioid small molecules designed to alleviate acute, chronic, and neuropathic pain without causing liver toxicity. This includes their lead clinical candidate, SRP-001, which received Fast Track designation from the U.S. FDA for acute pain on October 9, 2023, and is currently undergoing Phase 1 clinical trials (NCT05484414). Excluding potential patent term extensions, this patent is expected to grant South Rampart market exclusivity in EPO member states until 2038, aligning with the U.S. Patent No. 11,458,142 issued on October 4, 2022.
South Rampart has successfully secured patents for SRP-001 and other compounds in its portfolio in various key markets, including China, Hong Kong, Japan, India, Australia, Canada, Brazil, Russia, and Mexico, in addition to the U.S. and EU.
Dr. Hernan Bazan, South Rampart’s Co-founder and CEO, emphasized the significance of this European patent, as Europe is the second largest market for the commercialization of SRP-001. He noted that it strengthens their intellectual property portfolio and enhances their ability to address the substantial unmet medical need for safer, non-addictive pain medications, especially considering the risks associated with existing pain relief options.
The Fast Track designation granted by the U.S. FDA for SRP-001 in acute pain on October 4, 2023, allows for more frequent interactions with the FDA and expedites the drug’s clinical development plan and trial design. It also makes South Rampart eligible for Accelerated Approval or Priority Review and offers the option to use Rolling Review for the New Drug Application (NDA), allowing incremental submission of NDA sections.
Josh Blacher, South Rampart CFO, highlighted the company’s commitment to providing highly effective and safe pain relief options while addressing the safety risks associated with common pain medications like acetaminophen, NSAIDs, and opioids.
In August 2023, the company initiated its Phase 1 trial (multiple ascending dose study) and dosed the first patient. This study aims to assess the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of oral SRP-001 in healthy male and female volunteers. The trial is expected to be completed in November 2023.
About Pain Types:
• Acute pain signals immediate harm to the body, often short-lived and intense.
• Chronic pain persists or recurs for more than three months, affecting a significant portion of the global population.
• Neuropathic pain is caused by nerve damage and impacts around 7-10% of the general population. Existing medications have limitations and risks.
Pain management is a significant concern due to its impact on the quality of life and substantial economic burden. The U.S. alone spends over $635 billion annually on pain management healthcare costs, with a global economic impact estimated at $9.6 trillion.
About South Rampart Pharma, Inc.: South Rampart Pharma, Inc. is dedicated to advancing the safe treatment of pain by developing novel small molecule solutions that can overcome the risks associated with current pain medications. Their lead program, SRP-0011, is a First-in-Class analgesic with FDA Fast-Track Designation designed to reduce pain without the risks of opioids or acetaminophen’s liver toxicity. Phase 1 trial data is expected in 4Q 2023.
About South Rampart Pharma, Inc.: South Rampart Pharma, Inc. is dedicated to advancing the safe treatment of pain by developing novel small-molecule solutions that can overcome the risks associated with current pain medications. Their lead program, SRP-0011, is a First-in-Class analgesic with FDA Fast-Track Designation designed to reduce pain without the risks of opioids or acetaminophen’s liver toxicity. Phase 1 trial data is expected in 4Q 2023.
References:
- Rickard SM et al. “Chronic pain among adults – United States, 2019 – 2021” CDC Morb Mortal Wkly Rep. April 2023. PMID 37053114
- Cohen SP et al. “Chronic pain: an update on burden, best practices, and new advances” The Lancet May 2021. PMID: 34062143
- Substance Abuse and Mental Health Services Administration. “Key Substance Use and Mental Health Indicators in the United States: Results from the 2021 National Survey on Drug Use and Health” National Survey on Drug Use and Health. Jan 2023.
- Bazan HA et al. “A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis” European Journal of Medicinal Chemistry Sept 2020. PMID: 32629335
- Bazan HA et al. “Transcriptomic signature, bioactivity and safety of a non-hepatotoxic analgesic generating AM404 in the mid-brain PAG region” Nature Portfolio – under review DOI: doi.org/10.21203/rs.3.rs-2883310/v1
