Preclinical data with BBT001 demonstrate its best-in-disease potential for improved efficacy and dosing convenience compared to approved biologics in atopic dermatitis

Interim safety and pharmacokinetic data from healthy volunteers anticipated in 2H 2025

BOSTON,Feb. 28,2025 -- Bambusa Therapeutics,Inc. (Bambusa),a clinical-stage biotechnology company developing novel biologics for inflammatory and immunological diseases,today announced the initiation of dosing in healthy volunteers (HV) in its first clinical trial for BBT001,a novel,multi-targeting,half-life extended bispecific antibody,which is being developed initially as a treatment for atopic dermatitis (AD).

"The early initiation of the BBT001 Phase 1 clinical trial is a significant milestone for Bambusa as we continue to execute with excellence," said Shanshan Xu,M.D.,Ph.D.,Founder and Chief Executive Officer of Bambusa Therapeutics. "BBT001 represents a potential breakthrough in atopic dermatitis treatment by leveraging innovative antibody engineering to engage multiple,clinically validated,non-overlapping mechanisms of action. Our goal is to deliver faster onset of symptom relief,superior efficacy,and improved dosing convenience that could ultimately redefine the standard of care for AD patients."

About the BBT001-001 Clinical Trial

The Phase 1 clinical trial (BBT001-001; NCT06808477) is a randomized,placebo-controlled,single ascending dose (SAD) and multiple ascending dose (MAD) study evaluating BBT001 in healthy volunteers and adults with moderate to severe atopic dermatitis. The trial will assess the safety,tolerability,pharmacokinetics,immunogenicity,pharmacodynamics,and preliminary clinical activity of BBT001 and is expected to enroll approximately 98 participants across multiple cohorts. Interim safety and pharmacokinetic data are anticipated in the second half of 2025.

About BBT001 and 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.

Beyond BBT001,Bambusa is advancing BBT002,a bispecific antibody designed as a "platform in a molecule" with broad applications across respiratory,dermatology,and gastroenterology indications. The company's additional pipeline candidates,BBT003 and BBT004,are also being developed for inflammatory bowel disease and rheumatological conditions,each with best-in-disease potential.

About Atopic Dermatitis

Atopic dermatitis is a chronic inflammatory skin condition characterized by intense itching,dry skin,and recurrent eczematous lesions. It affects approximately 16.5 million adults in the United States alone and can have a significant impact on quality of life.[1] Despite recent therapeutic advances,including targeted biologics,a significant portion of patients continue to experience inadequate disease control,underscoring the need for novel treatment approaches.

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.

[1] https://aafa.org/wp-content/uploads/2022/08/Atopic-Dermatitis-in-America-Study-Overview.pdf