LSU Health Spin-off Company Announces Patient Enrollment and Dosing Underway in Phase 1 Study Evaluating Novel Non-Opioid Approach to Pain
South Rampart Pharma, a clinical-stage life science company focused on advancing innovative
medications for the treatment of pain and fever, announced recently that patient enrollment
and dosing in its Phase 1 study evaluating SRP-3D (DA) for pain is underway.
SRP-3D (DA) is South Rampart Pharma's lead program and is a novel acetaminophen analog with a unique mechanism of action that lacks the liver toxicity present in acetaminophen. It is in development to treat various forms of pain.
The technology is based on a small molecule discovered by Drs. Nicolas and Hernan Bazan. LSU Health Neuroscience Center of Excellence is serving as the research institution on a joint NIH/NINDS STTR ‘Fast-Track' grant with South Rampart Pharma. LSU Health's Office of Innovation and Partnerships has managed the relevant patent filings and assisted South Rampart Pharma with introductions to local and federal programs for funding and assistance.
“It has been gratifying to see an LSU Health-developed drug enter clinical trials, a first for our institution. Because of Tylenol's known toxicities and in the face of the opioid epidemic, new non-narcotic treatments for pain are essential,” said Patrick Reed, Assistant Vice Chancellor, Innovation & Partnerships.
Pain is one of the most prevalent and costly public health issues worldwide. In the U.S. alone, an estimated 20% (50 million) of adults experience chronic pain, and more than 76 million have suffered from pain that lasts longer than 24 hours. 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 over 100,000 drug overdose deaths in 2021, a nearly 30% increase from the same period the year before.
South Rampart Pharma is working to develop new small-molecule solutions that can overcome many risks associated with current pain medicines. The Company's lead compounds have effectively reduced pain and fever in preclinical studies without the liver and kidney toxicity of current non-opioid analgesics. As a new small molecule treatment option that is not a biologic therapy, South Rampart Pharma's compounds have great potential as a value product that will be low cost and accessible to many patients.
"Acute and chronic pain continues to be a huge problem globally,” said Nicolas Bazan, MD, PhD, Director of the LSU Health New Orleans Neuroscience Center of Excellence. “While pain relief options are widely available, there is a significant need for effective pain medications that do not come with the risks tied to current options. I believe SRP-3D (DA) represents a cutting-edge opportunity to treat pain effectively without the negative side effects associated with acetaminophen or NSAIDs."
“This is the very first drug discovered, patented, and developed at the LSU Health New Orleans approved by FDA for phase I clinical trials. It is now a proof of principle that effective translation of discoveries can be done at LSU Health New Orleans. We are beginning to apply this model to two other startups that I am working on with the opportunity to develop new drugs for neurological diseases currently without a cure,” he added.
Hernan Bazan, MD, DFSVS, FACS, CEO and co-founder of South Rampart Pharma, and Professor of Surgery at Ochsner Clinic said, “We are incredibly pleased with the progress of our SRP-3D (DA) program, our ability to meet NIH STTR milestones and to support the continued advancement of our clinical development pipeline on multiple fronts. The STTR fast-track award enabled us to pursue crucial pre-clinical work, including GLP toxicity studies, oral formulation development, and ultimate IND filing that brought our lead asset into the clinic. It also supported further pipeline expansion by developing our compound's novel intravenous formulation for post-operative pain. Several mechanisms of action studies added to our understanding of how the lead asset exerts pain relief while lacking liver toxicity. We look forward to continuing our efforts to bring our novel non-opioid approach forward to the high, unmet need of pain management that is safe, effective, and non-addictive.”
The ongoing Phase 1 study is a randomized, double-blind, placebo-controlled study
designed to assess the safety, tolerability, and pharmacokinetics (PK) of single ascending
oral doses of SRP-3D (DA). Further, it will characterize the pharmacodynamics and
food effect on SRP-3D (DA) in healthy male and female subjects. South Rampart Pharma
is enrolling 60 subjects in the Phase 1 study in Quotient Sciences, Miami, FL. The
primary endpoint for the study is to provide SRP-3D (DA)'s safety and tolerability
by assessing: adverse events, vital signs, electrocardiograms (ECGs), physical examinations,
and multiple laboratory safety tests.