The drug, SRP-001’s promising results from its phase 1 trial were also published.
The announcement was made by South Rampart Pharma Inc. and the study was led by Hernan Bazan, co-founder and CEO of South Rampart. It was titled “Transcriptomic signature, bioactivity and safety of a non-hepatotoxic analgesic generating AM404 in the midbrain PAG region,” and reveals that SRP-001 produces higher amounts of N-arachidonoylphenolamine (AM404) in the midbrain's periaqueductal grey (PAG) region than acetaminophen. This metabolite is crucial for inducing pain relief.
SRP-001 is highlighted as a safer alternative to existing pain medications, avoiding the abuse potential, liver toxicity, and kidney toxicity present in current treatments. According to comprehensive preclinical evaluations and a completed phase 1 randomized controlled trial (RCT) involving 56 human subjects, SRP-001 has demonstrated safety, tolerability, and robust pharmacokinetics.
These evaluations showed no adverse effects on liver, kidney, or other end-organs, making SRP-001 a significant addition to the pain management landscape.
“The quest for innovative pain solutions is critical, driven by the extensive prevalence of acute, chronic, and neuropathic pain,” said Dr Bazan.
“These pain conditions affect up to 27% of adults worldwide, including over 51 million adults in the U.S. Existing treatments such as opioids, acetaminophen, and NSAIDs pose risks of addiction and toxicity with overuse. Armed with known mechanisms for pain relief in the brain and compelling Phase 1 randomized trial data, we look forward to advancing SRP-001 into phase 2 randomized and controlled studies for acute and neuropathic pain in the second half of 2024.”
Company to launch phase 2 trial in acute pain
SRP-001 has been shown to trigger the formation of AM404, a potent activator of TRPV1 in the midbrain's PAG region, which plays a crucial role in the brain’s response to pain. Additionally, single-cell transcriptomics of the PAG region revealed that SRP-001 regulates pain-related gene expression and cell signaling networks, including endocannabinoid signaling and genes related to mechanical nociception and fatty acid amide hydrolase (FAAH).
The publication also emphasizes that SRP-001 avoids hepatotoxicity due to the absence of NAPQI formation and protects hepatic tight junction integrity. It does not carry the risks of kidney and gastrointestinal damage associated with NSAID overuse.
Comprehensive genotoxicity, safety pharmacology, and non-clinical toxicology evaluations, including ICH-compliant studies and GLP toxicity studies in two animal species, confirm SRP-001’s non-genotoxic nature and absence of adverse effects on pulmonary or cardiac functions.
The completed phase 1 RCT demonstrated that SRP-001 is safe and well-tolerated, with a half-life of up to 10.1 hours. With the FDA awarding SRP-001 Fast Track designation for acute pain in October 2023, the company is set to launch a phase 2 trial in acute pain in the second half of 2024, targeting neuropathic pain, acute/chronic pain, and patients with acute migraine headaches.
South Rampart Pharma, Inc. is a clinical-stage biopharmaceutical company committed to advancing the effective and safe treatment of pain by developing first-in-class novel small molecule therapeutics. The company aims to mitigate the prevalent risks of existing pain medications, such as addiction and organ damage, through its pipeline of novel compounds that have shown efficacy in reducing pain and fever in pre-clinical studies without the associated toxicities of current pain medicines.
