Brise Pharma Announces First Patient Dosed with BR01T in Phase I Study in Patients with Chronic Low Back Pain

SHANGHAI, Oct. 18, 2023 /PRNewswire/ -- 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."

About Brise Pharmaceuticals

Brise Pharma stands as a clinical stage biopharmaceutical company with a singular focus on the development of innovative and highly distinct analgesic treatments for severe pain conditions, placing a particular emphasis on addressing issues such as migraine, inflammatory pain, and neuropathic pain. The organization's vision encompasses the provision of safe, effective, and accessible pain relief solutions for the multitude of patients worldwide grappling with debilitating pain conditions.

About BR01T

Brise Pharmaceuticals' lead program, BR01T, represents a revolutionary anti-TrkA antibody with the potential to redefine the treatment landscape for CLBP. This target mechanism has garnered robust validation through preclinical and clinical data. What sets BR01T apart is its selective impact on crucial signaling pathways, facilitating optimal pain relief without the possible occurrence of bone-related side effects, such as bone damage. Furthermore, BR01T's inhibition of TrkA in both acute and chronic painful states introduces a novel mechanism of action that stands distinct from traditional opioids or nonsteroidal anti-inflammatory drugs (NSAIDs).

About MBR01T-101 CLBP Clinical Study

Chronic Low Back Pain (CLBP) constitutes a widespread and incapacitating condition affecting millions across the globe. Characterized by pain in the lower back that extends beyond a 12-week duration, CLBP lacks a specific underlying cause or disease. This condition exerts profound effects on affected individuals' quality of life, physical function, mental well-being, and socioeconomic status. The complexities of CLBP encompass a multifaceted interplay of biological, psychological, and environmental factors. Effective management necessitates a comprehensive, multidisciplinary approach tailored to each patient's preferences and needs. The core objectives of the MBR01T-101 clinical study encompass pain reduction, enhanced functionality, and the prevention of chronicity and disability.

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SOURCE Brise Pharmaceuticals Co., Ltd