BRB-002

PALO ALTO, Calif. and NEEDHAM, Mass. and MELBOURNE, Australia, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Bitterroot Bio, a leader in developing innovative medicines in the field of cardio-immunology, today announced the completion of enrollment in its Phase 1 study evaluating BRB-002 in healthy volunteers. This randomized, placebo-controlled, double-blinded, single ascending dose study is evaluating the safety, tolerability and target engagement of BRB-002 in thirty-six (36) healthy volunteers. Topline findings from the Phase 1 study are expected in early 2025. "We are thrilled to complete enrollment in our Phase 1 study for BRB-002," said Craig Basson, MD, PhD, Chief Medical Officer at Bitterroot Bio. "We look forward to sharing key results from this study early next year. Based on data from this study, we expect to begin our Phase 2 proof-of-concept trial in 2025 in patients with atherosclerosis in order to evaluate how this novel therapy can benefit these patients. Despite current treatment options, patients with atherosclerotic disease remain at significant residual risk for cardiovascular events. Our Phase 2 study will determine how BRB-002 can modify plaque to potentially decrease that risk." About BRB-002BRB-002 is a novel protein therapy that is being evaluated as an investigational agent in atherosclerotic cardiovascular disease (ASCVD). BRB-002 is an immuno-modulatory agent that inhibits the CD47 cell surface receptor (“don’t eat me” signal) to ameliorate the underlying causes of atherosclerosis and reduce inflammatory plaque burden. BRB-002 is currently being investigated in a Phase 1 clinical study directed by Bitterroot Australia Pty Ltd, a wholly owned subsidiary of Bitterroot Bio, Inc. About Bitterroot BioBitterroot Bio, Inc. is a pioneer in the emerging field of cardio-immunology, which investigates the interplay between the immune system and cardiovascular health. Bitterroot Bio’s research seeks to uncover critical roles that immune modulators play in the progression of cardiovascular disease. By targeting these diseases in this novel way, Bitterroot Bio’s mission is to transform the lives of those suffering from cardiovascular diseases. For more information, please visit https://www.brbio.com Media Contact: Emily Dale (Bitterroot Bio), media@brbio.com

PALO ALTO, Calif. and MELBOURNE, Australia, April 29, 2024 (GLOBE NEWSWIRE) -- Bitterroot BIo, a leader in developing innovative medicines in the field of cardio-immunology, today announced that the first human participants have been dosed in a Phase 1 study of BRB-002 in healthy volunteers. BRB-002 is a novel protein therapy targeting CD47 that is being investigated as a potential treatment option for patients with atherosclerotic cardiovascular disease (ASCVD). The Phase 1 trial is evaluating the safety and tolerability of subcutaneously administered BRB-002 in healthy volunteers. Bitterroot Australia Pty Ltd, a wholly owned subsidiary of Bitterroot Bio, Inc., is directing this clinical trial in partnership with the Nucleus Network in Brisbane. "The initiation of this Phase 1 trial is a vital step forward in our mission to address unmet cardiovascular needs, and marks Bitterroot’s transformation into a clinical-stage company," said Craig Basson, MD, PhD, Chief Medical Officer of Bitterroot Bio. "This milestone reflects our team's hard work and dedication to advancing cardiovascular science by developing a novel medicine in ASCVD. We are optimistic about the potential of BRB-002 to make a meaningful difference in the lives of patients and are committed to rigorously evaluating its safety and efficacy in the clinic." About BRB-002 BRB-002 is a novel protein therapy that is being evaluated as an investigational agent in atherosclerotic cardiovascular disease (ASCVD). BRB-002 inhibits the CD47 cell surface receptor ("don’t eat me" signal) to address the underlying causes of atherosclerosis and vascular inflammation. In preclinical studies, BRB-002 has been shown to attenuate atherosclerosis in both prevention and established disease models. BRB-002 is currently being investigated in a Phase 1 clinical study. About Bitterroot Bio Bitterroot Bio, Inc. is a pioneer in the emerging field of cardio-immunology, which investigates the interplay between the immune system and cardiovascular health. Bitterroot Bio’s research discoveries have uncovered critical roles that immune cells and modulators of inflammation play in the initiation and progression of cardiovascular disease. Our ultimate goal is to provide new hope to those suffering from cardiovascular diseases by transforming the way these diseases are treated. For more information, please visit Media Contact: Emily Dale (Bitterroot Bio), media@brbio.com