Bitterroot Bio Completes Enrollment in Phase 1 First-in-Human Study of BRB-002 in Healthy Volunteers

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-002
BRB-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 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 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