Oct. 12, 2023
The Fast Track designation accelerates SRP-001’s path to U.S. FDA submission for the treatment of acute pain
Enhanced time-to-market delivers a therapeutic alternative to habit-forming opioids and acetaminophen, the leading cause of acute liver failure in the U.S.
NEW ORLEANS, Oct. 12, 2023 – South Rampart Pharma, Inc. (“South Rampart” or the “Company”), a clinical-stage biopharmaceutical company targeting the safer treatment of pain, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company for SRP-001 for the treatment of acute pain. SRP-001 is a novel, first-in-class non-opioid analgesic that activates pain signaling pathways in the midbrain’s periaqueductal grey (PAG) region without liver and kidney toxicities. The Fast Track designation facilitates the development and expedites the review of new therapies for serious conditions, aiming to bring important new drugs to patients earlier and address unmet medical needs.
Notably, Fast Track designation enables the following:
- More frequent meetings and written communication with the FDA to discuss the clinical development plan and clinical trial design and ensure the collection of appropriate data needed to support drug approval;
- Eligibility for Accelerated Approval or Priority Review, if relevant criteria are met; and
- Rolling Review, which allows the Company to submit completed sections of its New Drug Application (NDA) for review rather than waiting for the completion of all sections of the NDA before the application is reviewed.
“Despite the ongoing opioid crisis and limitations of existing pain medications, including acetaminophen as the leading cause of acute liver failure in the U.S. and other parts of the Western world, innovation in the pain space remains surprisingly stagnant,” said Hernan Bazan, MD, CEO & Co-Founder of South Rampart Pharma. “Today’s acknowledgment by the FDA of the critical need for innovative medications in acute pain perfectly matches our unwavering commitment to expedite its clinical development and bring this potentially transformative therapy to market as swiftly as possible.”
“In the CNS and pain space, Fast Track designation for SRP-001 isn’t just a regulatory milestone; it’s a commercial accelerant. This designation recognizes the scientific innovation behind SRP-001 and potential market impact as a safer, more effective alternative to opioids and acetaminophen,” said Neil Singla, MD, Chief Scientific Officer at Lotus Clinical Research.
In August 2023, South Rampart announced that the first patient of its Phase 1 trial (NCT05484414), a multiple ascending dose (MAD) study, had been dosed. The primary objective of the MAD study is to assess the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of oral SRP-001 in 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 Q4 2023.
About South Rampart Pharma, Inc.
South Rampart Pharma, Inc. is a clinical-stage biotech company focused on addressing the critical need for a safer, more 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 the PAG region’s endocannabinoid, mechanical nociception, and fatty acid amide hydrolase pathways. 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 has demonstrated repeated efficacy in several non-clinical pain models, including the inflammatory von Frey, visceral, and somatic pain models. Interim results from the Phase 1 trial (NCT05484414) demonstrate SRP-001’s safety, tolerability, and robust 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.
Josh Blacher, MBA
Chief Financial Officer