Health

South Rampart declares patient dosing & enrollment in SRP-3D evaluation

South Rampart declares patient dosing & enrollment in SRP-3D evaluation
South Rampart Pharma, a clinical-stage life science firm, has reportedly announced patient admission and dosing in its Phase 1 study assessing SRP-3D (DA) for pain.

According to Hernan Bazan, M.D., the Co-Founder and Chief Executive Officer of South Rampart Pharma and Professor of Surgery at the Ochsner Clinic, SRP-3D (DA) has showcased promising efficiency in curbing both fever and pain while lacking kidney and liver toxicity related to the existing prescription and OTC (over-the-counter) analgesics.

Mr. Bazan is pleased with the development and clinical progress of SRP-3D (DA) and the company understands its necessity for the market. Through the initiation of patient dosing and enrolment, the company continues to advance towards registering topline results which are expected in Q3 of this year.

It is worth noting that SRP-3D (DA), the lead program of South Rampart, is an advanced acetaminophen analog with a distinct mechanism of action that lacks the toxicity of the liver present in acetaminophen.

The ongoing Phase 1 study is a double-blind, randomized, placebo-controlled study developed to evaluate the tolerability, safety, and PK (pharmacokinetics) of single ascending SRP-3D (DA) oral doses. Additionally, it will characterize the food effect and pharmacodynamics on SRP-3D (DA) in healthy female as well as male subjects.

The Louisiana-based company is admitting 60 subjects in the Phase 1 study in Quotient Sciences, Miami. The primary endpoint for the study is to offer the safety and tolerability of SRP-3D (DA) by evaluating vital signs, electrocardiograms (ECGs), adverse events (AEs), multiple laboratory safety tests, and physical examinations.

Secondary endpoints of the study comprise oral pharmacokinetics of SAD (single ascending dose) of SRP-3D (DA) provided as an oral suspension, followed by several ascending doses.

Interestingly, pain is one of the most costly and prevalent public health issues across the world. In the United States alone, approximately 20% of adults suffer from chronic pain.

Source credits: https://www.biospace.com/article/releases/south-rampart-pharma-announces-patient-enrollment-and-dosing-underway-in-phase-1-study-evaluating-novel-non-opioid-approach-to-pain-with-lead-program-srp-3d-da-/

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