BRB-002 / Bitterroot Bio - LARVOL DELTA

A study to assess the safety and tolerability of BRB-002 in adults with established atherosclerosis (ANZCTR) - P2 | N=52 | Recruiting | Sponsor: Bitterroot Bio Australia Pty Ltd | Not yet recruiting ➔ Recruiting | Initiation date: May 2025

Enrollment open • Trial initiation date • Atherosclerosis • Cardiovascular • CRP

A study to assess the safety and tolerability of BRB-002 in adults with established atherosclerosis (ANZCTR) - P2 | N=52 | Not yet recruiting | Sponsor: Bitterroot Bio Australia Pty Ltd

New P2 trial • Atherosclerosis • Cardiovascular • CRP

DEVELOPMENT OF BRB-002, A NOVEL NEXT-GENERATION ANTI-CD47 MOLECULE, FOR ATHEROSCLEROTIC CARDIOVASCULAR DISEASE - B Alexander Yi (ACC 2025) - "These results suggest that CD47 blockade has potential as a novel therapy for atherosclerosis. Based on these observations, a first-in-man study of subcutaneously administered BRB-002 is currently being investigated in an ongoing phase 1 clinical trial and results will be presented."

Atherosclerosis • Cardiovascular • APOE • SIRPA

Bitterroot Bio to Present Detailed Results from Phase 1 Study of BRB-002 at American College of Cardiology Annual Scientific Session 2025 (GlobeNewswire) - "Bitterroot Bio...announced today that the Company will present results from the Phase 1 study of BRB-002 in healthy volunteers at the American College of Cardiology (ACC) Annual Scientific Session 2025, taking place in Chicago, Illinois, March 29 – 31, 2025." "

P1 data • Cardiovascular

Bitterroot Bio Reports Data on Safety and Target Engagement from Phase 1 First-in-Human Study of BRB-002 in Healthy Volunteers (GlobeNewswire) - P1 | N=48 | ACTRN12624000405516 | Sponsor: Bitterroot Australia Pty Ltd | "Bitterroot Bio, a leader in developing innovative medicines in the field of cardio-immunology, today announced positive results from a recently completed Phase 1 study of BRB-002 in healthy volunteers. Safety: BRB-002 was safe at all doses tested with no serious adverse events described. Target engagement: CD47 receptor occupancy increased in a dose-dependent manner, ranging up to 100% receptor occupancy at the highest doses tested...A Phase 2 proof-of-concept trial of BRB-002 in patients with established atherosclerosis is expected to initiate in the first half of 2025."

New P2 trial • P1 data • Atherosclerosis

BRB-002, a novel next-generation immuno-modulatory agent targeting CD47 for Atherosclerotic Cardiovascular Disease (CVCT USA 2024) - No abstract available

Immunomodulating • Atherosclerosis • Cardiovascular

Phase 1 study of BRB-002 in healthy male volunteers (ANZCTR) - P1 | N=48 | Recruiting | Sponsor: Bitterroot Australia Pty Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Apr 2024

Enrollment open • Trial initiation date • Cardiovascular

Phase 1 study of BRB-002 in healthy male volunteers (ANZCTR) - P1 | N=48 | Not yet recruiting | Sponsor: Bitterroot Australia Pty Ltd

New P1 trial • Cardiovascular