South Rampart Pharma Publishes SRP-001's Pain Relief Mechanism and Phase 1 Results in Scientific Reports

South Rampart Pharma, Inc. has announced significant findings regarding their novel pain relief compound, SRP-001, as published in Scientific Reports. This new pain medication aims to address the limitations and risks associated with current treatments by introducing a non-opioid, non-toxic alternative.

SRP-001's novel mechanism involves triggering the formation of N-arachidonoylphenolamine (AM404) in the midbrain's periaqueductal grey (PAG) region. AM404 is a potent activator of TRPV1, a receptor known to play a crucial role in the body's response to pain. The publication highlights that SRP-001 produces higher levels of AM404 than acetaminophen, which is significant for pain relief.

The Phase 1 trial results, included in the publication, demonstrate that SRP-001 is safe and well-tolerated. Conducted with 56 participants, the trial revealed that the compound has favorable pharmacokinetics, making it ready for Phase 2 trials in treating neuropathic pain, acute and chronic pain, and acute migraine headaches. With the FDA awarding SRP-001 Fast Track designation for acute pain in October 2023, South Rampart Pharma plans to launch a Phase 2 trial in the second half of 2024.

Key findings from the study include that SRP-001 induces AM404 formation in the midbrain PAG region, significantly impacting pain-related gene expression and cell signaling networks. The compound regulates critical genes involved in endocannabinoid signaling, mechanical nociception, and fatty acid amide hydrolase (FAAH).

SRP-001's safety profile is impressive, showing no hepatotoxicity due to the absence of NAPQI formation and protecting hepatic tight junctions' integrity. As a non-NSAID, it avoids the risks of kidney and gastrointestinal damage common with overuse of nonsteroidal anti-inflammatory drugs. Comprehensive genotoxicity, safety pharmacology, and non-clinical toxicology evaluations confirmed its non-genotoxic nature and lack of adverse effects on pulmonary or cardiac functions.

A Phase 1 randomized controlled trial (RCT) involving 56 subjects showcased SRP-001's safety and tolerability, with a half-life extending up to 10.1 hours. This positions SRP-001 as a promising candidate for further clinical development.

Dr. Hernan Bazan, the study's lead author and South Rampart's co-founder and CEO, emphasized the importance of innovative pain solutions given the widespread prevalence of acute, chronic, and neuropathic pain. He noted that existing treatments, such as opioids, acetaminophen, and NSAIDs, pose significant risks, including addiction and toxicity. The compelling Phase 1 trial data for SRP-001 underscores its potential to advance into Phase 2 trials for various pain conditions, including migraine headaches, in 2024.

Acute, chronic, and neuropathic pain present significant health challenges. Acute pain is an immediate response to injury, usually intense but short-lived. Chronic pain persists beyond three months, affecting millions of adults worldwide. Neuropathic pain, caused by nerve damage, also impacts a substantial portion of the population. Traditional treatments often fall short, carrying risks like addiction and organ damage. The opioid epidemic highlights the urgent need for safer pain management solutions.

Migraine, a complex neurological condition, affects nearly 40 million Americans and over 1 billion people globally. Characterized by severe headaches and other debilitating symptoms, migraines significantly impact daily life.

South Rampart Pharma is dedicated to developing first-in-class novel small molecule therapeutics to provide effective and safe pain treatment. Their lead program, SRP-001, represents a significant advancement by targeting the midbrain's PAG region, offering a potentially effective pain relief solution without the risks associated with current pain medications. With a successful Phase 1 trial completed, SRP-001 is poised for Phase 2 trials in the near future.