Bitterroot Bio Finishes Phase 1 BRB-002 Study Enrollment

PALO ALTO, Calif. and NEEDHAM, Mass. and MELBOURNE, Australia, Oct. 29, 2024 – Bitterroot Bio, a prominent player in the field of cardio-immunology, has successfully completed the participant enrollment for its Phase 1 clinical trial of BRB-002 in healthy individuals. This study, which is both randomized and placebo-controlled, follows a double-blind methodology to examine the safety, tolerability, and target engagement of the BRB-002 therapy in a group of thirty-six (36) healthy volunteers. Initial results from this Phase 1 trial are anticipated to be available in early 2025.

Craig Basson, MD, PhD, the Chief Medical Officer at Bitterroot Bio, expressed considerable enthusiasm about the completion of enrollment, stating, "We are excited to have reached this milestone in our Phase 1 study for BRB-002. We anticipate sharing crucial findings from this investigation early next year. The data from this study will propel us toward initiating our Phase 2 proof-of-concept trial in 2025. This trial will focus on patients with atherosclerosis and evaluate the potential benefits of this novel therapy. Despite existing treatment options, individuals with atherosclerotic disease still face a substantial residual risk of cardiovascular events. Our Phase 2 study will explore how BRB-002 can modify plaque to possibly mitigate that risk."

BRB-002 is an innovative protein therapy candidate under investigation for its potential use in treating atherosclerotic cardiovascular disease (ASCVD). As an immuno-modulatory agent, BRB-002 works by inhibiting the CD47 cell surface receptor, often referred to as the “don’t eat me” signal, to address the root causes of atherosclerosis and lessen inflammatory plaque build-up. The Phase 1 clinical trial of BRB-002 is currently being managed by Bitterroot Australia Pty Ltd, which is a fully owned subsidiary of Bitterroot Bio, Inc.

Bitterroot Bio, Inc. is at the forefront of the emerging cardio-immunology sector, which studies the interaction between the immune system and cardiovascular health. The company’s research aims to uncover the significant roles that immune modulators play in the progression of cardiovascular diseases. By targeting these diseases through this unique approach, Bitterroot Bio is dedicated to transforming the lives of individuals suffering from cardiovascular conditions.