Sept. 22, 2022
South Rampart Pharma (“South Rampart” or the “Company”), a clinical-stage life science company advancing innovative medications for the treatment of pain and fever, today announced that it received a Notice of Award from the National Institutes of Health (NIH) regarding Year 3 of its Small Business Technology Transfer (STTR) grant.
The NIH grant is entitled ‘Novel non-narcotic analgesic for acute and chronic pain.’ South Rampart Pharma will receive the Year 3 incremental Award of the $1.9M grant administered through the NIH’s National Institute of Neurological Disorders and Stroke (NINDS), which will continue to help support the development of SRP-001, the Company’s lead drug candidate.
SRP-001 is a novel, non-opioid small molecule with the potential to overcome many risks associated with current pain medicines, including the liver toxicity of acetaminophen. Importantly, SRP-001 mirrors acetaminophen’s clinically validated mechanism of action while simultaneously muting the biological activity that causes liver toxicity. South Rampart Pharma is currently conducting an ongoing Phase 1 trial evaluating the safety, tolerability, and pharmacokinetics of SRP-001.
“From my clinical experience in treating post-operating patients, there is an urgent need to develop and commercialize safer analgesics to treat acute pain. The continued financial support of the NIH plays a crucial role in enabling our solution to this clinical problem and the advancement of our clinical pipeline,” commented Hernan Bazan, M.D., F.A.C.S., Chief Executive Officer and Co-Founder of South Rampart Pharma and the Endowed John Ochsner Professor of Surgery at the Ochsner Clinic. “Our non-toxic, non-opioid molecule may be the answer to an epidemic of liver failure associated with acetaminophen — the leading cause of acute liver failure in the United States — and could transform pain management. This vote of confidence from the NIH underscores just how important and promising this work is.”
South Rampart Pharma’s lead program, SRP-001, is a novel acetaminophen analog with a unique mechanism of action for its lack of liver toxicity present in acetaminophen. Both non-clinical and clinical data generated to date supports SRP-001’s highly differentiated competitive positioning, which includes:
- Ability to reduce both pain and fever
- No liver toxicity at even high dose treatment
- No high dose-associated kidney toxicity
- No abuse potential given it is a non-opioid
The ongoing Phase 1 clinical trial (Clinicaltrials.gov Identifier: NCT05484414) currently enrolls up to 60 patients in a randomized, double-blind, placebo-controlled study with endpoints assessing the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending oral doses of SRP-001. Further, it will characterize the pharmacodynamics and food effect on SRP-001. The Phase 1 study is being conducted at Quotient Sciences in Miami, FL, known for its excellence in supporting the needed clinical pharmacology of Phase 1 studies. Phase 2 clinical trials are planned to begin in 2023.
Pain is one of the most prevalent and costly public health issues worldwide1. In the U.S. alone, an estimated 20% (50 million) of adults experience chronic pain2, and more than 76 million have suffered from pain that lasts longer than 24 hours3. Currently available medications are either highly addictive or cause harm to the liver and kidney. For example, acetaminophen hepatotoxicity remains the most common cause of acute liver failure in the U.S., and opioids were associated with more than 100,000 drug overdose deaths in 20214, a nearly 30% increase from the 78,056 deaths during the same period the year before.
William K. Schmidt, Ph.D., a world expert on analgesic drug development and Chairperson for the Annual Arrowhead Pain Summit, added, “The scientific basis underlying the pain relief and lack of liver toxicity are important mechanisms for this lead asset. I believe SRP-001 may represent a cutting-edge opportunity to treat pain effectively, and importantly, without the hepatic, gastrointestinal, cardiovascular, or kidney toxicity commonly associated with acetaminophen or NSAIDs.”
The Small Business Innovation Research (SBIR) and STTR, collectively the Small Business Programs, are also known as America’s Seed Fund. By setting aside more than $1.2 billion from its Research & Development Funding specifically for Small Business Programs, the NIH supports promising early-stage small businesses nationwide after a rigorous review of a technology’s scientific merit and commercialization potential. The STTR grant is administered through the NIH’s National Institute of Neurological Disorders and Stroke (NINDS). South Rampart Pharma’s award entitled ‘Novel non-narcotic analgesic for acute and chronic pain’ is being conducted in collaboration with the Louisiana State University Health Sciences Center (LSUHSC) Neuroscience Center of Excellence through the end of 2023.
South Rampart Pharma is a clinical-stage life science company dedicated to advancing the safe treatment of pain by developing new small molecule solutions that can overcome many risks associated with current pain medicines. The Company’s pipeline of novel compounds has effectively reduced both pain and fever in pre-clinical studies without the liver and kidney toxicity of current non-opioid analgesics. The Company’s lead program, SRP-001, is currently in a Phase 1 study evaluating the safety, tolerability, and pharmacokinetics with data expected in 023.
Maxim Jacobs, CFA
- Relieving Pain in America. (2011). National Academy of Sciences. doi: 10.17226/13172
- Prevalence of Chronic Pain and High-Impact Chronic Pain Among Adults – United States, 2016. (2019, September 16). Retrieved from https://www.cdc.gov/mmwr/volumes/67/wr/mm6736a2.htm?s_cid=mm6736a2_w.
- Partners for Understanding Pain. (n.d.). TOOL KIT – The ACPA Health Care Professionals September 2019. Retrieved from Tool-Kit-2019-Final-8-27-19.pdf.
SOURCE South Rampart Pharma