South Rampart Pharma picks Validcare for Phase 2 SRP-001 pain trial

South Rampart Pharma has selected Validcare to run operations for a Phase 2 study of SRP-001 in moderate-to-severe acute postoperative pain, with first dosing imminent at CenExel Research in Salt Lake City. The companies say the trial will use Validcare’s SmartSource platform and could report topline data in late Q1 2027.

Why it matters: - South Rampart Pharma is advancing SRP-001 in a Phase 2 trial aimed at treating acute postoperative pain without opioids. - The study could help determine whether SRP-001 can deliver pain relief while avoiding opioid addiction risk and some common safety concerns tied to other pain medicines. - Fast trial execution matters because South Rampart Pharma expects topline results in late Q1 2027.

What happened: - South Rampart Pharma selected Validcare to manage clinical operations, data management, and electronic outcomes capture for the Phase 2 SRP-001 trial. - Site activation and first-participant dosing are imminent. - The trial is running at CenExel Research in Salt Lake City, Utah, under Principal Investigator Todd M. Bertoch, MD. - Validcare will also deploy its SmartSource Clinical Trial Platform for real-time source data collection and monitoring.

The details: - The study is a randomized, double-blind, placebo-controlled, parallel-group trial. - The trial will test a single 2,000 mg oral dose of SRP-001 nanosuspension against matching placebo in a 1:1 allocation. - The study plans to enroll 130 adults with moderate-to-severe pain, defined as an NPRS score of 5 or higher, after surgical extraction of two or more third molars, including at least two bone-impacted mandibular molars. - The Dental Impaction Pain Model is an FDA-recognized acute surgical pain model used to measure analgesic onset, peak effect, and duration of action. - The primary endpoint is time-weighted Sum of Pain Intensity Differences over 0 to 6 hours, analyzed with ANCOVA. - Key secondary endpoints include time to onset, Total Pain Relief, and 24-hour rescue analgesic and opioid use. - South Rampart Pharma expects to report topline Phase 2 results in late Q1 2027. - Validcare will handle workflow across site-based and remote participant activities from consent through last visit. - The company says the platform is designed to improve source data quality and shorten database lock timelines versus traditional methods.

Between the lines: - South Rampart Pharma is pairing the trial with a regulatory push, signaling that Phase 2 execution and FDA strategy are moving together. - The company framed SRP-001 as a non-opioid option designed to cross the blood-brain barrier and engage central pain inhibition. - That positioning puts SRP-001 into a crowded pain-treatment market where efficacy and safety tradeoffs remain a major hurdle. - Sarah Popham, MS, RAC, was appointed head of regulatory affairs as the company prepares for broader development work. - Popham brings more than 20 years of biopharmaceutical regulatory experience in central nervous system and acute pain therapeutics. - Her prior role was vice president of regulatory affairs at Latigo Biotherapeutics, where she led regulatory strategy, IND submissions, and FDA interactions for non-opioid pain candidates. - South Rampart Pharma already has FDA Fast Track designation for SRP-001.

What's next: - The first participant is expected to be dosed soon. - The Phase 2 trial will move through enrollment and follow-up at the Salt Lake City site. - South Rampart Pharma and Validcare will support data capture and monitoring through trial completion. - The company will be watching for late Q1 2027 topline results.

The bottom line: - South Rampart Pharma is moving SRP-001 deeper into clinical development with a CRO partner, a defined regulatory lead, and a near-term readout on the calendar.