South Rampart Pharma Expands Global Patent Portfolio with EU Approval for FDA Fast-Tracked SRP-001 for Pain

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Nov 01, 2023, 07:05 ET

South Rampart's Global Intellectual Property Portfolio Now Includes Patents in Key Markets: United States, Europe, Greater China, India, Japan, S. Korea, Australia, Canada, Brazil, Russia, and Mexico

NEW ORLEANS, Nov. 1, 2023 /PRNewswire/ -- South Rampart Pharma, Inc. ("South Rampart" or the "Company"), a clinical-stage life science company focused on developing innovative pain treatments, announced today the issuance 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, entitled "Compositions and methods for ameliorating pain," encompasses the methods and composition of matter for a library of novel non-opioid small molecules devoid of liver toxicity for acute, chronic, and neuropathic pain. This includes the Company's lead clinical candidate, SRP-001, which the U.S. FDA granted Fast Track designation for acute pain on October 9, 2023, and is ending Phase 1 clinical trials (NCT05484414). This patent, excluding possible patent term extensions, is expected to provide South Rampart with market exclusivity in the EPO member states until 2038, aligning with the U.S. Patent No. 11,458,142, issued on October 4, 2022. In addition to the U.S. and EU, South Rampart has successfully obtained patents for SRP-001 and other compounds in its portfolio in China, Hong Kong, Japan, India, and Australia, as well as in Canada, Brazil, Russia, and Mexico.

"Next to the United States, Europe remains the second largest market for the ultimate commercialization of SRP-001, so today's announcement further secures our ability to tap into the substantial unmet medical need for next-generation, non-addictive pain medications," commented Dr. Hernan Bazan, South Rampart's Co-founder and CEO. "Coupled with prior USPTO allowances, today's EPO announcement bolsters our robust IP portfolio around SRP-001's unique mechanisms and PK, amplifying its long-term market potential. Given the prevalent issues of liver failure from paracetamol/acetaminophen, kidney and gastrointestinal risks from NSAIDs, and addiction and overdose risks from opioids, our focus remains on delivering a safer therapeutic alternative in the pain management sector," concluded Dr. Bazan.

On October 4, 2023, the U.S. FDA granted Fast Track designation to SRP-001 for acute pain. The FDA Fast Track designation allows for more frequent interactions with the FDA, streamlining the clinical development plan and trial design to expedite drug approval. Additionally, the Company gains eligibility for Accelerated Approval or Priority Review and, further, can utilize Rolling Review to submit sections of its New Drug Application (NDA) incrementally rather than waiting for the entire application to be completed. South Rampart CFO Josh Blacher added, "We believe offering pain relief options that are highly effective and easy-to-use, while improving on the safety risks of acetaminophen, NSAIDS, and opioids represents a strong commercial opportunity."

In August 2023, South Rampart announced that the first patient of its Phase 1 trial, multiple ascending dose (MAD) study, has been dosed. The primary objective of the MAD study is to assess the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of oral SRP-001 to healthy male and female volunteers, with the primary endpoints being safety and tolerability by assessing adverse events (AEs), vital signs, electrocardiograms (ECGs), physical examinations, laboratory safety tests, and select PK/PD parameters. The trial will be completed in November 2023.

About Acute, Chronic, and Neuropathic Pain
Acute, chronic, and neuropathic pain represent distinct yet interconnected medical challenges. Acute pain is akin to a biological alarm, often short-lived but intense, signaling immediate harm to the body. Chronic pain is pain that persists or recurs for longer than three months, and it exerts an enormous personal and economic burden, affecting 51.6 million adults in the U.S. in 2021¹ and up to 30% of people worldwide². Neuropathic pain, stemming from nerve damage, impacts around 7-10% of the general population. Current medications, including opioids, acetaminophen/paracetamol, and nonsteroidal anti-inflammatory drugs (NSAIDs), offer limited relief and have significant drawbacks, such as addiction and organ toxicity. The opioid crisis has further complicated the landscape, with 8.7 million people aged 12 or older misusing prescription opioids in the U.S. alone³. These forms of pain degrade the quality of life and pose a significant economic burden. The U.S. spends over $635 billion annually on pain management healthcare costs, and the global economic impact is estimated at $9.6 trillion².

About South Rampart Pharma, Inc.
South Rampart Pharma, Inc. is a clinical-stage life science company dedicated to advancing the safe treatment of pain by developing best-in-class novel small molecule solutions that can overcome many risks associated with current pain medicines. The Company's pipeline of novel compounds has effectively reduced pain and fever in pre-clinical studies without current non-opioid analgesics and liver and kidney toxicity⁴. The Company's lead program, SRP-0011, is a First-in-Class analgesic with FDA Fast-Track Designation that targets the midbrain's PAG region without opioids' abuse risk or acetaminophen's liver toxicity⁵. Phase 1 trial data ensures safety and robust pharmacokinetics [ClinicalTrials.gov Identifier: NCT05484414], with data 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