Brise Pharmaceuticals Co., LTD., a pioneering company specializing in innovative treatments for chronic pain, has taken a significant step forward with the commencement of dosing for the initial participants in its Phase 1 clinical trial, designated MBR01T-101. The trial focuses on the safety and tolerability study of BR01T, a groundbreaking monoclonal antibody designed to target Tropomyosin Receptor Kinase (TrkA) for addressing Chronic Low Back Pain (CLBP).
The MBR01T-101 trial, structured as a randomized, double-blind, and placebo-controlled study, aims to enroll approximately 56 patients with chronic low back pain. The trial is set to be conducted at a prestigious JBR CenExel clinical research center located in Salt Lake City, Utah, USA. The primary objectives of this trial are to assess both the safety and effectiveness of the BR01T treatment in patients with chronic low back pain.
Dr. Eric Liu, Chief Medical Officer of Brise Pharmaceuticals, expressed enthusiasm about this significant stride, stating, “Starting this first-in-patient study of BR01T is a major milestone for Brise Pharma, as we advance our clinical portfolio into the realm of chronic pain conditions. An anti-TrkA antibody holds the promise to revolutionize the landscape of chronic low back pain by providing sustained relief. Our overarching goal is to empower chronic low back pain sufferers around the globe to regain control of their lives through the potential of BR01T.”