Bambusa Therapeutics Announces First Subject Dosed in Phase 1 Clinical Trial of BBT002, A Novel Platform-In-A-Molecule Bispecific Antibody for Broad I&I Conditions and U.S. FDA Clearance of IND Application for BBT001

• Preclinical data with BBT002 demonstrate its best-in-disease potential for improved efficacy and dosing convenience across respiratory, dermatology, and gastroenterology indications
• Interim safety and pharmacokinetic data from BBT002-01 study anticipated in Q1 2026
• The clearance of BBT001-01 study expands the clinical development territory of BBT001 beyond Australia into the United States
• Bambusa has successfully advanced two differentiated bispecific programs—BBT001 and BBT002—into the clinic within 12 months of the company's founding, underscoring its execution-first culture and translational rigor

BOSTON, May 30, 2025 /PRNewswire/ -- Bambusa Therapeutics, Inc. (Bambusa), a clinical-stage biotechnology company developing novel biologics for inflammatory and immunological diseases, today announced that it has completed the initial dosing in healthy volunteers (HV) in its clinical trial for BBT002, a novel, half-life extended bispecific antibody designed as a "platform in a molecule" with broad applications across respiratory, dermatology, and gastroenterology.

The Phase 1 clinical trial (BBT002-001; NCT06944925) is a randomized, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study evaluating BBT002 in healthy volunteers and adults with COPD. The study will evaluate safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and preliminary efficacy of BBT002. Approximately 96 participants are expected to enroll across multiple sites. Interim safety and pharmacokinetic data are anticipated in the first quarter of 2026. Bambusa is also considering expanding into additional indications including asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, eosinophilic esophagitis and food allergy, to fully realize the "platform-in-a-molecule" potential for BBT002.

"Advancing our second program into the clinic within just 12 months of founding Bambusa reflects the speed, precision, and high standards that define our development culture," said Thang Ho, PhD, Senior Vice President of Development Sciences at Bambusa Therapeutics. "BBT002's dual-target mechanism leverages two of the most classic and fundamental inflammatory pathways—enabling a rational, biology-driven approach to push the efficacy ceiling beyond what single-target therapies can achieve. We believe this strategy may offer additive or synergistic benefit, particularly for patients with complex, multi-organ inflammatory diseases. This milestone highlights our team's ability to rapidly translate bold science into clinical-stage programs with broad impact."

Separately, Bambusa also announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to proceed with the clinical development of BBT001, a novel multi-targeting, half-life extended bispecific antibody for the treatment of atopic dermatitis and other inflammatory skin diseases.  BBT001 is currently being studied in a randomized, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study conducted in Australia, evaluating BBT001 in healthy volunteers and adults with moderate to severe atopic dermatitis. 

About Bambusa's pipeline

BBT001 is a novel half-life extended bispecific antibody. Preclinical data with BBT001 demonstrate its best-in-disease potential, offering enhanced efficacy and improved dosing convenience compared to approved biologics in atopic dermatitis. It is currently being tested in a Phase I clinical study (BBT001-001; NCT06808477) 

BBT002 is a novel half-life extended bispecific antibody designed as a "platform in a molecule" with broad applications across respiratory, dermatology, and gastroenterology indications. Preclinical data with BBT002 demonstrate its best-in-disease potential, offering enhanced efficacy and improved dosing convenience compared to approved biologics across multiple inflammatory conditions. It is currently being tested in a Phase I clinical study (BBT002-001; NCT06944925).

The company's additional pipeline candidates, BBT003 and BBT004, are being developed for inflammatory bowel disease and rheumatological conditions, each with best-in-disease potential.

About Bambusa Therapeutics

Bambusa Therapeutics is a clinical-stage biotechnology company specializing in developing transformative inflammatory and immunological therapeutics. Based in the vibrant Boston Seaport area, Bambusa's mission is to advance the field of immunology with cutting-edge solutions. For more information, visit www.bambusatx.com.

SOURCE Bambusa Therapeutics