Aug. 25, 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 the Company will present a late-breaking abstract at the International Association for the Study of Pain (IASP) 2022 World Congress on Pain, which will take place on September 20-23, 2022, in Toronto, Canada.
The late-breaking presentation, entitled “Novel Non-Opioid Analgesic for Acute and Chronic Pain: From Discovery to Phase 1 Trial,” will chronicle the invention and development of SRP-001 (previously known as SRP-3D (DA)). Central to SRP-001’s therapeutic differentiation, this non-opioid investigational pain medication exhibits comparable, if not better, efficacy as similar approved drugs but notably does not exhibit their liver or kidney toxicity. South Rampart’s CEO and Co-founder, Hernan Bazan, MD, FACS, will deliver the presentation.
“I’m delighted to have this opportunity to showcase the groundbreaking work we’ve done with SRP-001,” commented Dr. Bazan. “Liver toxicity associated with acetaminophen is the leading cause of acute liver failure in the United States. As a practicing vascular surgeon, I have routinely informed my practices in the ER and beyond.” Dr. Bazan continued, “During the rationale design of SRP-001, we specifically set out to engineer a next-generation analgesic that both maintains the integrity of the clinically validated mechanism of action as acetaminophen while simultaneously muting the biological activity that leads to liver toxicity, thereby widening the therapeutic index by an order of magnitude. As such, we believe SRP-001 represents a unique opportunity to potentially transform the treatment of pain — replacing existing treatments — and deliver everyday relief on a significant scale.” The World Congress on Pain is the largest global gathering of pain professionals. This event brings together more than 7,000 scientists, clinicians, and healthcare providers worldwide and across the pain discipline.
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. In development to treat acute and other forms of pain, evidence to date demonstrates that SRP-001 offers a compelling safety profile over currently available pain medications, including:
- Ability to reduce both pain and fever
- No liver toxicity despite 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) is enrolling 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 have 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 Q2 2023.
Maxim Jacobs, CFA
1 Relieving Pain in America. (2011). National Academy of Sciences. doi: 10.17226/13172
2 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.
3 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