South Rampart Pharma Achieves Development Milestone and Advances to Phase II of Active NIH Fast-Track STTR Commercialization Award

$1.9 million NIH fast-track STTR grant fuels next stage of clinical program dedicated to the development of a novel non-opioid approach to pain management

Lead program SRP-3D (DA) advances in ongoing Phase 1 clinical trial with data expected in the third quarter of 2022

NEW ORLEANS, May 4, 2022 /PRNewswire/ -- 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 it achieved milestones outlined in the Phase I portion of its Small Business Technology Transfer (STTR) grant (1R42NS119103) received from the National Institutes of Health (NIH) and advanced to the Phase II portion of its NIH grant. The 'fast-track' combined Phase I/II award provides for $1.9 million of funding to support the ongoing clinical development of the Company's lead small molecule, SRP-3D (DA), a novel non-opioid therapeutic candidate. South Rampart Pharma currently is completing the single ascending dose phase of the Phase 1 clinical trial of SRP-3D (DA) and remains on track to report topline results from the study in the third quarter of 2022.

"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," said Hernan Bazan, M.D., F.A.C.S., Chief Executive Officer and Co-Founder of South Rampart Pharma and Professor of Surgery at the Ochsner Clinic. "The STTR fast-track award enabled us to pursue important 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 with the development of a novel intravenous formulation of our compound for post-operative pain, in addition to several mechanisms of action studies that 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."

A Differentiated Approach to Pain Management Innovation

South Rampart Pharma's lead program, SRP-3D (DA), is a novel acetaminophen analog with a unique mechanism of action that notably lacks the liver toxicity present in acetaminophen. In development to treat acute and other forms of pain, pre-clinical research to date demonstrates that SRP-3D (DA) offers a compelling safety profile over currently available pain medications, including:

• Demonstrating ability to reduce both pain and fever
• No liver toxicity seen with high dose treatment
• No high-dose associated kidney toxicity
• Favorable liver metabolic profile (cytochrome P450)
• No abuse potential given non-opioid approach

The ongoing Phase 1 clinical trial is enrolling 60 patients in a randomized, double-blind, placebo-controlled study with endpoints assessing the safety, tolerability, and pharmacokinetics (P.K.) of single and multiple ascending oral doses of SRP-3D (DA). Further, it will characterize the pharmacodynamics and food effect on SRP-3D (DA).  The Phase 1 study is being conducted at Quotient Sciences in Miami, FL, known for its excellence at determining the needed clinical pharmacology of Phase 1 studies.  Data are expected in the third quarter of 2022.

Addressing the Ineffective Standard of Care in Pain Management

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 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-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."

About NIH STTR Award

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 throughout the nation after rigorous review of a technology's scientific merit and commercialization potential. The STTR grant is administered through the National Institute of Neurological Disorders and Stroke (NINDS) at the NIH. 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.

About South Rampart Pharma

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-3D (Diethylamide [DA]) is currently in a Phase 1 study evaluating the safety, tolerability, and pharmacokinetics with data expected in the third quarter of 2022.

Please visit the Company's website at southrampart.com and connect on Twitter and LinkedIn for more information.

[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.
⁴ https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2021/20211117.htm

Investors:
Maxim Jacobs, CFA
Russo Partners
[email protected]
(646) 942-5591

Media Relations:
Gideon Broshy
Russo Partners
[email protected]
(347) 956-7563

SOURCE South Rampart Pharma