South Rampart Pharma Announces First Patient Enrolled in Multiple Ascending Dose Portion of Ongoing Phase 1 Clinical Trial

 - SRP-001, a novel, non-opioid investigational drug that avoids the liver toxicity associated with acetaminophen, positioned to address the unmet medical need for non-toxic and non-addictive acute and chronic pain therapeutics -

 - Data expected in 3Q 2023 -

NEW ORLEANS, Aug. 22, 2023 /PRNewswire/ -- South Rampart Pharma, Inc. ("South Rampart" or the "Company"), a clinical-stage life science company advancing innovative medications for the treatment of pain, today announced that the first patient of its Phase 1 trial, multiple ascending dose (MAD) study, has been dosed. The primary objective of the MAD study is to assess the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of oral SRP-001 to healthy male and female volunteers, with the primary endpoints being safety and tolerability by assessing adverse events (AEs), vital signs, electrocardiograms (ECGs), physical examinations, laboratory safety tests, and select PK/PD parameters. The trial is expected to be completed in the third quarter of 2023.

In the MAD study, the initial SRP-001 dose for Cohort 1 is 500 mg, administered orally once daily (QD) for five days. The dosage for Cohort 2 will be data driven. There will be eight volunteers per cohort (6 active, 2 placebo) in a 1:1 male-to-female ratio.

"The hepatotoxicity of existing pain medications, namely acetaminophen, is the primary cause of acute fulminant liver failure in the United States," commented Dr. Hernan Bazan, MD, FACS, CEO and Co-Founder of South Rampart Pharma. "Moreover," continued Dr. Bazan, "overuse of non-steroidal inflammatory drugs (NSAIDs) has significant risks to the kidney and gastrointestinal tract. The other widely used category of acute pain relief, opioids, have well-documented concerns of life-altering addiction. This enormous and urgent unmet medical need is the problem we've set out to solve at South Rampart Pharma."

The MAD study continues the Company's earlier Phase 1 trial, a single ascending dose (SAD) study, in which the company administered SRP-001 to 40 patients. The initial dose of SRP-001 in the SAD study was 300 mg, with subsequent dose increases to 600, 900, and 2,000 mg. Importantly, no serious adverse events (SAEs) or changes in laboratory values, including a robust PK profile, were established in the SAD study.

Dr. Neil Singla, MD, Chief Scientific Officer and Founder of Lotus Clinical Research, added, "SRP-001 has incredible promise as an efficacious NME analgesic that avoids the pernicious side effects of acetaminophen and NSAIDs."  South Rampart Pharma intends to launch a proof-of-concept Phase 2 trial upon generating supportive data from the MAD study, which would evaluate the safety and efficacy of SRP-001 in patients undergoing 3rd molar extraction, a well-established acute pain model. This study will enroll 200 patients in a randomized, double-blind, placebo- and comparator-controlled, multi-center study.

About South Rampart Pharma
South Rampart Pharma, Inc. is a clinical-stage biotech company focused on addressing the critical need for a safe and effective approach to relieving pain. Its lead clinical candidate, SRP-001, is a novel, first-in-class analgesic that activates pain signaling pathways in the midbrain's periaqueductal grey (PAG) region. SRP-001 influences pain-related genes through endocannabinoid, mechanical nociception, and fatty acid amide hydrolase pathways in the PAG region. Unlike opioids, SRP-001 doesn't carry a risk of abuse and addiction. Moreover, it lacks the hepatotoxicity associated with acetaminophen as it does not produce the harmful metabolite NAPQI nor disrupt liver cell tight junctions. Compared with acetaminophen, SRP-001 exhibits similar analgesic properties without the risk of liver damage, and it lacks NSAIDs' kidney toxicity risk. SRP-001 is effective in non-clinical pain models, including the inflammatory von Frey, visceral, and somatic pain models. Interim results from the ongoing Phase 1 trials (NCT05484414) demonstrate SRP-001's safety, tolerability, and favorable pharmacokinetics. SRP-001 represents a promising alternative to existing pain medicines like opioids, acetaminophen, and NSAIDs potentially providing a safer, more effective pain treatment option.

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

Investors:
Josh Blacher, MBA
Chief Financial Officer
[email protected]

SOURCE South Rampart Pharma