South Rampart Pharma Advances to Phase 2 with Neuropathic and Acute Pain Trials

South Rampart Pharma, a company in the clinical stage of life sciences, has announced the successful completion of a Phase 1 trial for a novel pain treatment. The trial involved a drug named SRP-001, which is a first-of-its-kind analgesic that targets a specific region in the midbrain known as the PAG. The study was a randomized, double-blind, and placebo-controlled research that focused on the safety, tolerability, and pharmacokinetics of SRP-001 in healthy volunteers.

The trial, conducted in partnership with Quotient Sciences in Miami, Florida, was a significant step forward, as SRP-001 has been granted the FDA Fast-Track designation, highlighting its potential for treating pain safely and effectively. The demand for innovative pain treatments is high, given the limitations of current medications and the substantial impact of acute, chronic, and neuropathic pain on the population. Chronic pain alone affects over 51.6 million adults in the U.S., and current treatments such as opioids, acetaminophen, and NSAIDs come with risks of addiction and toxicity.

The Phase 1 trial involved 56 healthy volunteers and reported no serious adverse events. The pharmacokinetic profile of SRP-001 showed a half-life of 10.1 hours, which is notably longer than that of existing pain medications. The data collected from the trial provided a comprehensive understanding of the drug's behavior in the body, including its absorption, distribution, metabolism, and excretion.

Dr. Hernan Bazan, the Co-founder and CEO of South Rampart, expressed enthusiasm for advancing SRP-001 into proof-of-concept studies. He believes that SRP-001's safety profile, pharmacokinetics, and non-habit-forming nature, along with its known central nervous system targets for efficacy, offer significant advantages over current treatments and could revolutionize next-generation pain medications.

South Rampart is planning two Phase 2 randomized and controlled studies. One will evaluate the efficacy of SRP-001 for treating diabetic peripheral neuropathic pain, comparing it to pregabalin. The other study will assess the drug's effectiveness in treating acute pain in patients undergoing a dental procedure, in comparison to a combination of acetaminophen and oxycodone.

The FDA's Fast Track designation, granted on October 4, 2023, for acute pain, allows for more frequent interactions with the FDA, streamlining the clinical development plan and trial design to expedite drug approval. South Rampart's CFO, Josh Blacher, emphasized the potential of SRP-001 to address a significant market opportunity in pain management, which is estimated to be approaching $100 billion worldwide.

South Rampart Pharma is dedicated to developing novel small molecule solutions for pain treatment that mitigate the risks associated with current pain medicines. Their lead program, SRP-001, targets the PAG region without the abuse risk associated with opioids or the liver toxicity of acetaminophen. The Phase 1 trial data supports the safety and robust pharmacokinetics of the drug, with data expected to be released in the fourth quarter of 2023.