South Rampart Pharma Selects Validcare to Manage Phase 2 Trial of Non-Opioid SRP-001 for Acute Postoperative Pain

SAN FRANCISCO, CA AND CASTLE PINES, CO, UNITED STATES, November 3, 2026 /EINPresswire.com/ — Highlights:

– Site activation and first-participant dosing imminent in 130-participant randomized, double-blind, placebo-controlled trial at CenExel Research under Principal Investigator Todd M. Bertoch, MD

– Validcare deploying its SmartSource™ Clinical Trial Platform (CTP) for real-time source data collection and monitoring

– Phase 2 execution and FDA Fast Track regulatory strategy for SRP-001 supported by the appointment of Sarah Popham, MS, RAC, former Vice President of Regulatory Affairs at Latigo Biotherapeutics, as Head of Regulatory Affairs

South Rampart Pharma, Inc. (“South Rampart Pharma”), a clinical-stage biotechnology company developing next-generation non-opioid therapeutics for acute and chronic pain, and Validcare, LLC (“Validcare”), a clinical research organization (CRO) delivering technology-enabled clinical trial operations, today announced that South Rampart Pharma has selected Validcare to manage clinical operations, data management, and electronic outcomes capture for its Phase 2 clinical trial evaluating SRP-001 for moderate-to-severe acute postoperative pain. Site activation and first-participant dosing is imminent.

The Phase 2 study is a randomized, double-blind, placebo-controlled, parallel-group trial evaluating a single 2,000 mg oral dose of SRP-001 nanosuspension versus matching placebo (1:1 allocation) in 130 adult participants experiencing moderate-to-severe pain (NPRS ≥ 5) following the surgical extraction of two or more third molars, including at least two bone-impacted mandibular molars. The trial is being conducted at CenExel Research in Salt Lake City, Utah, under Principal Investigator Todd M. Bertoch, MD. The Dental Impaction Pain Model (DIPM) is an FDA-recognized acute surgical pain model characterized by standardized bony trauma and assay sensitivity for quantifying analgesic onset, peak effect, and duration of action. The primary efficacy endpoint is the time-weighted Sum of Pain Intensity Differences over 0 to 6 hours (SPID(0-6)) analyzed via Analysis of Covariance (ANCOVA), with key secondary endpoints assessing time to onset, Total Pain Relief (TOTPAR), and 24-hour rescue analgesic and opioid use. Based on the single-center, high-throughput trial design, South Rampart Pharma anticipates reporting topline Phase 2 results in late Q1 2027.

Under the agreement, Validcare will provide full CRO services powered by its SmartSource™ Clinical Trial Platform (CTP) Participant to automate and manage data collection, monitoring and the trial’s site-based and remote workflow for participants, investigators, and the Validcare teams. This approach optimizes source data collection and oversight from consent through last visit; improving data integrity and reducing the time to achieve database lock versus traditional methods.

“In acute postoperative pain trials, protecting assay sensitivity requires disciplined execution around baseline pain qualification, serial bedside ePRO timestamps, double-stopwatch recording, and rescue medication intervals,” said Hernan A. Bazan, MD, DFSVS, FACS, Chief Executive Officer and Co-Founder of South Rampart Pharma. “Partnering with Validcare alongside Dr. Bertoch’s team at CenExel gives us a tightly integrated operational infrastructure as we prepare to dose our first participant. While peripheral sodium channel (Nav 1.8) inhibitors have recently entered the market, clinicians and participants remain constrained by peripheral efficacy ceilings, opioid addiction risks, NSAID renal and gastrointestinal toxicities, and acetaminophen-induced hepatotoxicity. SRP-001 is designed to address this gap by crossing the blood-brain barrier to engage central descending pain inhibition without forming hepatotoxic metabolites.”

“Acute surgical pain studies require real-time data visibility from the moment a participant qualifies post-operatively through outpatient follow-up,” said Patrick C. McCarthy, Esq., Chief Executive Officer of Validcare. “By deploying Validcare’s digital capture platform at CenExel, we eliminate paper transcription delays and standardize protocol compliance across both site-based and at-home assessment windows. We look forward to supporting South Rampart Pharma through Phase 2 execution of this differentiated non-opioid program.”

Regulatory Leadership Appointment

In conjunction with Phase 2 initiation, South Rampart Pharma announced the appointment of Sarah Popham, MS, RAC, as Head of Regulatory Affairs. Ms. Popham brings over 20 years of biopharmaceutical regulatory experience in central nervous system and acute pain therapeutics. Most recently, she served as Vice President of Regulatory Affairs at Latigo Biotherapeutics, where she led regulatory strategy, IND submissions, and FDA interactions for non-opioid pain candidates.

“SRP-001 combines a centrally acting analgesic mechanism with a differentiated hepatic safety profile,” said Sarah Popham, MS, RAC, Head of Regulatory Affairs at South Rampart Pharma. “With FDA Fast Track designation already granted, I look forward to working with Validcare, CenExel, and the FDA to advance SRP-001 efficiently through clinical development.”

About Validcare, LLC

Validcare is a global, full service, results-based Clinical Research Organization delivering radically faster, more reliable clinical trials for life sciences pioneers. We align incentives through fixed-price, milestone-based contracts. We combine a world-class clinical operations team with SmartSource™, our direct source data platform. The result: Real Time Clinical Trials designed for speed, reliability, and results—for sponsors and patients. Founded by experts with more than 30 years of executive-level industry experience, Validcare helps to bring life-changing products to market.

About South Rampart Pharma, Inc.

South Rampart Pharma, Inc. is a San Francisco-based, clinical-stage biotechnology company developing patented, non-opioid, non-hepatotoxic small molecules for acute and chronic pain. Its lead candidate, SRP-001 (FDA Fast Track designation), crosses the blood-brain barrier to generate AM404 in the midbrain periaqueductal gray (PAG), recruiting dual FAAH/TRPV1 signaling and restoring pain-disrupted synaptic gene networks without hepatotoxic metabolite formation. In a 56-subject Phase 1 trial (NCT05484414), oral SRP-001 demonstrated rapid absorption (Tmax ~ 1 hour), a 9–10 hour elimination half-life, and safety with no liver enzyme elevations, sedation, or cardiovascular findings. Supported by the National Institutes of Health (NIH), learn more at southrampartpharma.com.

Contacts:

Validcare, LLC: Scott Hardin, shardin@validcare.com or 844-825-4322

South Rampart Pharma, Inc.: Josh Blacher, MBA, Chief Financial Officer, jblacher@southrampartpharma.com

Scott Hardin
Validcare LLC
+1 844-825-4322

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