Bitterroot Bio finishes recruiting for Phase 1 human trial of BRB-002 with healthy participants

Bitterroot Bio, a front-runner in the advancement of novel therapies within cardio-immunology, has confirmed the conclusion of participant enrollment for its Phase 1 trial assessing BRB-002 in healthy subjects.

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This randomized, placebo-controlled, double-blind study involving a single ascending dose is assessing the safety, tolerability, and target engagement of BRB-002 in a cohort of thirty-six (36) healthy participants. The primary results from the Phase 1 investigation are anticipated by early 2025.

"We are excited to announce the completion of enrollment for our Phase 1 trial of BRB-002," stated Craig Basson, MD, PhD, Chief Medical Officer at Bitterroot Bio. "We are eager to present the important findings from this study in the coming year. Based on the outcomes from this trial, we plan to initiate our Phase 2 proof-of-concept study in 2025, focusing on patients with atherosclerosis to determine the benefits of this innovative therapy. Despite available treatments, individuals with atherosclerotic conditions still face considerable residual cardiovascular event risks. Our Phase 2 trial aims to explore how BRB-002 may alter plaque formation and potentially reduce that risk."

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According to the data provided by the Synapse Database, As of October 31, 2024, there are 12 investigational drugs for the CD47 x SIRPα target, including 9 indication, 11 R&D institutions involved, with related clinical trial reaching 5, and as many as 4610 patents.

BRB-002 is an immune cell therapy drug developed by Bitterroot Bio, Inc. The drug targets CD47 x SIRPα and is intended for the treatment of cardiovascular diseases, specifically atherosclerosis. The highest phase of development for BRB-002 is currently Phase 1.