NEW ORLEANS (press release) – South Rampart Pharma Inc., a clinical-stage life science company focused on developing innovative pain treatments, has announced the issuance of European Patent No. 3672938 by the European Patent Office effective Nov. 1, 2023. This patent will apply to all Unified Patent Court-participating and non- participating European Unitary member states.
The patent, titled “Compositions and methods for ameliorating pain,” encompasses the methods and composition of matter for a library of novel non-opioid small molecules devoid of liver toxicity for acute, chronic, and neuropathic pain. This includes the Company’s lead clinical candidate, SRP-001, which the United States FDA granted Fast Track designation for acute pain on Oct. 9, 2023, and is ending Phase 1 clinical trials (NCT05484414). This patent, excluding possible patent term extensions, is expected to provide South Rampart with market exclusivity in the EPO member states until 2038, aligning with the U.S. Patent No. 11,458,142, issued on Oct. 4, 2022. In addition to the U.S. and EU, South Rampart has successfully obtained patents for SRP-001 and other compounds in its portfolio in China, Hong Kong, Japan, India, and Australia, as well as in Canada, Brazil, Russia and Mexico.
“Next to the United States, Europe remains the second largest market for the ultimate commercialization of SRP-001, so today’s announcement further secures our ability to tap into the substantial unmet medical need for next-generation, non-addictive pain medications,” said Dr. Hernan Bazan, South Rampart’s co-founder and CEO. “Coupled with prior USPTO allowances, today’s EPO announcement bolsters our robust IP portfolio around SRP-001’s unique mechanisms and PK, amplifying its long-term market potential. Given the prevalent issues of liver failure from paracetamol/acetaminophen, kidney and gastrointestinal risks from NSAIDs, and addiction and overdose risks from opioids, our focus remains on delivering a safer therapeutic alternative in the pain management sector.”
On Oct. 4, 2023, the U.S. FDA granted Fast Track designation to SRP-001 for acute pain. The FDA Fast Track designation allows for more frequent interactions with the FDA, streamlining the clinical development plan and trial design to expedite drug approval. Additionally, the Company gains eligibility for Accelerated Approval or Priority Review and, further, can utilize Rolling Review to submit sections of its New Drug Application (NDA) incrementally rather than waiting for the entire application to be completed. South Rampart CFO Josh Blacher added, “We believe offering pain relief options that are highly effective and easy-to-use, while improving on the safety risks of acetaminophen, NSAIDS, and opioids represents a strong commercial opportunity.”
In August 2023, South Rampart 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 will be completed in November 2023.
