South Rampart Pharma Announces Patient Enrollment and Dosing Underway in Phase 1 Study Evaluating Novel Non-Opioid Approach to Pain with Lead Program, SRP-3D (DA)

2022-03-23

SRP-3D(AD)疼痛合作小分子药物

South Rampart Pharma ("South Rampart" or the "Company"), a clinical-stage life science company focused on advancing innovative medications for the treatment of pain and fever, announced today patient enrollment and dosing in its Phase 1 study evaluating SRP-3D (DA) for pain is underway.

"We are committed to improving the lives of people suffering from acute, chronic, or neuropathic pain by developing a new class of small molecule, non-opioid pain medicines. To date, SRP-3D (DA) has shown promising efficacy in reducing both pain and fever while lacking the liver and kidney toxicity associated with current prescription and over-the-counter analgesics," said Hernan Bazan, M.D., Chief Executive Officer and Co-Founder of South Rampart Pharma and Professor of Surgery at the Ochsner Clinic. "We are pleased with SRP-3D (DA)'s development and clinical progress, and we know the market needs this. With patient enrollment and dosing now well underway, we continue to advance toward reporting topline results, expected in the third quarter of this year."

The Company's lead program, SRP-3D (DA), 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 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 (AEs), vital signs, electrocardiograms (ECGs), physical examinations, and multiple laboratory safety tests. Secondary endpoints include oral PK of single ascending dose (SAD) of SRP-3D (DA) administered as an oral suspension, followed by multiple ascending doses.

"Acute and chronicpain continues to affect a growing section of the global population. While opioids, acetaminophen, ibuprofen, and similar NSAIDs are widely available, there remains a significant need for effective pain medications with fewer adverse effects and without the abuse liability of opioid analgesics. I believe SRP-3D (DA) 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," added William K. Schmidt, Ph.D., Chairperson for the Annual Arrowhead Pain Summit and expert on analgesic drug development.

Pain is one of the most prevalent and costly public health issues worldwide[1]. In the U.S. alone, an estimated 20% (50 million) of adults experience chronic pain[2], and more than 76 million have suffered from pain that lasts longer than 24 hours[3]. 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 20214, a nearly 30% increase from the 78,056 deaths during the same period the year before.

South Rampart Pharma's proprietary compounds have consistently reduced pain and fever in preclinical studies without liver and kidney toxicity associated with current common over-the-counter analgesics. In all of the Company's FDA Investigational New Drug (IND)-enabling toxicology studies, SRP-3D (DA) was shown to have a favorable safety profile. Additionally, as a non-opioid SRP-3D (DA) lacks abuse potential.

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