South Rampart Pharma Successfully Completes Phase 1 Study and Expands Phase 2 Plans to Include Neuropathic and Acute Pain Trials

News provided by

Jan 02, 2024, 07:05 ET

Phase 1 data demonstrate that SRP-001 exhibits an exceptionally strong safety and robust pharmacokinetic profile and is well-tolerated
Well-designed Phase 2 trials set to show statistical significance compared to placebo and positive control

NEW ORLEANS, Jan. 2, 2024 /PRNewswire/ -- South Rampart Pharma, Inc. ("South Rampart" or the "Company"), a clinical-stage life science company focused on developing innovative pain treatments, announced today that it has successfully completed a Phase 1 trial (NCT05484414). The Phase 1 randomized clinical trial (RCT) of SRP-001, a first-in-class analgesic targeting the midbrain's PAG region, was a randomized, double-blind, placebo-controlled study assessing the safety, tolerability, and pharmacokinetics (PK) of SRP-001 in healthy subjects. Conducted in collaboration with Quotient Sciences in Miami, Florida, the trial's completion marks a significant milestone, as SRP-001 has now received U.S. FDA Fast-Track designation, underscoring its potential in the safe and effective treatment of pain.

The demand for new pain solutions is significant due to the vast number of individuals affected by various forms of pain and the limitations of current medications. Acute, chronic, and neuropathic pain collectively impact a substantial portion of the population, with chronic pain affecting over 51.6 million adults in the U.S. alone¹, and current treatments like opioids, acetaminophen, and NSAIDs presenting issues like addiction and toxicity with overuse. These result in a substantial economic burden, with the U.S. spending over $635 billion annually on pain management and a global impact estimated at $9.6 trillion².

Phase 1 RCT design and key findings:

Participant Cohort: 56 healthy volunteers participated in the trial across both Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) phases.
Safety Profile: The study reported no serious adverse events (SAEs). Clinical laboratory evaluations indicated no abnormalities, including clinical chemistry, hematology, urinalysis, vital signs, ECG, and physical examinations. Normal liver and kidney function tests support the Company's earlier findings.
Pharmacokinetics: SRP-001 demonstrated a half-life of 10.1 hours, significantly longer than existing pain medications. The PK profile included a detailed analysis of Tmax, Cmax, AUC(0-tau), AUC(0-last), AUC(0-inf), and T1/2, providing a comprehensive understanding of the drug's behavior in the body.

Data Reporting and Analysis:

Cohort Summaries: The study compiled detailed reports on dosing, participant status, adverse events, and protocol deviations, ensuring thorough quality control and data integrity.
PK Data: Extensive PK data was collected and analyzed, including plasma concentration-time profiles for various dosages in both SAD and MAD phases. This data was crucial in understanding the drug's absorption, distribution, metabolism, and excretion.

"Now well-equipped with compelling Phase 1 data, we are enthusiastic to advance SRP-001 into proof-of-concept studies, with two well-designed Phase 2 randomized and controlled studies," commented Dr. Hernan Bazan, South Rampart's Co-founder and CEO. "We believe SRP-001's highly differentiated safety and PK profile, coupled with its non-habit-forming attributes and known targets in the CNS for its efficacy, potentially offer clear advantages over existing treatments and could very well shift the paradigm of next-generation pain medications," concluded Dr. Bazan.

The Company is currently planning Phase 2 RCTs as follows:

Neuropathic Pain: A Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial evaluating the efficacy of low- and high-doses of SRP-001 for the treatment of diabetic peripheral neuropathic (DPN) pain (n=200) [vs. pregabalin (Lyrica®)]. The primary endpoint will be the change from baseline in the Weekly Average of Daily Pain Intensity on a Numeric Pain Rating Scale (NPRS) [Time Frame: Baseline, Week 12], in addition to various secondary endpoints.
Acute Pain: A Phase 2, randomized, double-blind, placebo- and comparator-controlled, multicenter trial to evaluate the efficacy of increasing doses of SRP-001 for treating acute pain in subjects undergoing 3rd molar extraction (n=200) [vs. acetaminophen/oxycodone]. The primary endpoint will be the summed pain intensity difference from hour 0 to 6 (SPID6), including various secondary endpoints.

On October 4, 2023, the U.S. FDA granted South Rampart Fast Track designation 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. South Rampart CFO Josh Blacher added, "There is no doubt that SRP-001 offers a highly differentiated solution to multiple pain indications in dire need of better alternatives. The opportunity we are addressing in acute, chronic, and neuropathic pain is approaching $100 billion worldwide, and we believe we are exceptionally well positioned relative to our competitors in the pipeline of truly innovative investigational drugs."

About Acute, Chronic, and Neuropathic Pain
Acute, chronic, and neuropathic pain represent distinct yet interconnected medical challenges. Acute pain is akin to a biological alarm, often short-lived but intense, signaling immediate harm to the body. Chronic pain is pain that persists or recurs for longer than three months, and it exerts an enormous personal and economic burden, affecting 51.6 million adults in the U.S. in 2021¹ and up to 30% of people worldwide². Neuropathic pain, stemming from nerve damage, impacts around 7-10% of the general population. Current medications, including opioids, acetaminophen/paracetamol, and nonsteroidal anti-inflammatory drugs (NSAIDs), offer limited relief and have significant drawbacks, such as addiction and organ toxicity. The opioid crisis has further complicated the landscape, with 8.7 million people aged 12 or older misusing prescription opioids in the U.S. alone³. These forms of pain degrade the quality of life and pose a significant economic burden.

About South Rampart Pharma, Inc.
South Rampart Pharma, Inc. is a clinical-stage life science company dedicated to advancing the safe treatment of pain by developing best-in-class novel small molecule solutions that can overcome many risks associated with current pain medicines. The Company's pipeline of novel compounds has effectively reduced pain and fever in pre-clinical studies without current non-opioid analgesics and liver and kidney toxicity⁴. The Company's lead program, SRP-001, is a First-in-Class analgesic with FDA Fast-Track Designation that targets the midbrain's PAG region without opioids' abuse risk or acetaminophen's liver toxicity⁵. Phase 1 trial data ensures safety and robust pharmacokinetics [ClinicalTrials.gov Identifier: NCT05484414], with data expected in 4Q 2023.

References:

Rickard SM et al. "Chronic pain among adults – United States, 2019 – 2021" CDC Morb Mortal Wkly Rep. April 2023. PMID 37053114
Cohen SP et al. "Chronic pain: an update on burden, best practices, and new advances" The Lancet May 2021. PMID: 34062143
Substance Abuse and Mental Health Services Administration. "Key Substance Use and Mental Health Indicators in the United States: Results from the 2021 National Survey on Drug Use and Health" National Survey on Drug Use and Health. Jan 2023.
Bazan HA et al. "A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis" European Journal of Medicinal Chemistry Sept 2020. PMID: 32629335
Bazan HA et al. "Transcriptomic signature, bioactivity and safety of a non-hepatotoxic analgesic generating AM404 in the mid-brain PAG region" Nature Portfolio – under review DOI: doi.org/10.21203/rs.3.rs-2883310/v1