Bitterroot Bio will present Phase 1 study results for BRB-002, a novel anti-CD47 therapy for atherosclerotic cardiovascular disease (ASCVD), at the American College of Cardiology’s 2025 Scientific Session. The study in healthy volunteers met its primary safety objective, showing no serious adverse events and demonstrating dose-dependent target engagement with up to 100% CD47 receptor occupancy at the highest doses. The presentation will be delivered by Dr. Alexander Yi on March 29, 2025.
These findings are potentially crucial for advancing the treatment of ASCVD. Current treatments often focus on managing symptoms and risk factors, but BRB-002’s mechanism, inhibiting the “don’t eat me” signal of CD47, could offer a novel way to address the underlying inflammation driving atherosclerosis and plaque buildup. This potential to modify the disease course rather than just manage symptoms makes BRB-002 a promising candidate in a field with a high unmet need for more effective therapies. Positive Phase 1 results could attract further investment and accelerate the development of this much-needed treatment.
The Phase 1 study demonstrated both safety and target engagement, which are critical milestones for any new drug candidate. Achieving high CD47 receptor occupancy suggests the drug is effectively binding to its target, offering a strong rationale for progressing to further clinical trials. This successful early trial lays the groundwork for evaluating the drug’s efficacy in patients with ASCVD.
The upcoming presentation at ACC represents a key inflection point for Bitterroot Bio. Positive reception of these early findings could significantly raise the company’s profile within the cardio-immunology field and generate excitement about the potential of BRB-002. This could pave the way for future collaborations, partnerships, and further funding to advance the clinical development of this promising therapy and potentially reshape the ASCVD treatment landscape.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
