Bambusa Therapeutics Hits Two Major Milestones with BBT001

Bambusa Therapeutics, Inc., a clinical-stage biotech advancing next-generation bispecific antibodies, announced two landmark achievements for its lead candidate, BBT001.

Strong Phase I Results in Healthy Volunteers

At the EADV 2025 Congress, Bambusa presented highly positive data from the single ascending dose portion of its ongoing Phase I trial. Key findings included:

• Favorable safety across all dose levels with no dose-limiting adverse events.
• Best-in-class pharmacokinetics with a ~33-day half-life, enabling flexible dosing.
• Rapid, complete, and sustained IL-4Rα binding and pSTAT6 inhibition through Week 8+.
• Unprecedented reduction in TARC levels—dose-dependent, deep, and sustained through Week 8+.

“These results provide the first clinical evidence of BBT001’s potential to become a best-in-disease biologic in atopic dermatitis,”

• Thang Ho, Ph.D., SVP of Development Sciences.

He added that the data suggest synergy between IL-4Rα and IL-31 inhibition, potentially delivering faster onset and deeper relief for patients with type 2 inflammatory skin diseases.

First Patient Dosed in Atopic Dermatitis

This week, Bambusa reached its next milestone: the first patient with moderate-to-severe atopic dermatitis has been dosed in the ongoing Phase I trial.

“Achieving patient dosing within 16 months of our inception underscores our pace of execution. We now feel a deep responsibility to accelerate development, generate proof-of-concept data, and redefine the standard of care.”

• Shanshan Xu, M.D., Ph.D., CEO and Founder.

About the BBT001-001 Trial

• Design: Randomized, placebo-controlled, single- and multiple-ascending-dose.
• Participants: Healthy volunteers and adults with moderate-to-severe atopic dermatitis.
• Endpoints: Safety, tolerability, PK, immunogenicity, pharmacodynamics, and early clinical activity.
• Status: Enrollment ongoing; additional data expected in 2026.

About BBT001

BBT001 is a first-in-class, half-life extended bispecific antibody engineered to block IL-4Rα and IL-31 signaling. The dual mechanism is designed to address type 2 inflammation and directly target itch pathways, offering faster and more durable relief.

The molecule has already shown a favorable safety profile and strong PK in healthy volunteers, supporting advancement into patient studies.

About Bambusa Therapeutics

Bambusa Therapeutics is a Boston-based clinical-stage biotech focused on next-generation bispecific antibodies for chronic diseases. Its pipeline includes:

• BBT001 – Targeting IL-4Rα and IL-31, now in Phase I for atopic dermatitis and type 2 inflammatory skin diseases.
• BBT002 – Targeting IL-4Rα and IL-5, in Phase I for COPD, asthma, and CRSwNP.
• BBT003/BBT004 – Preclinical programs in gastroenterology and rheumatology.

Powered by its antibody engineering platform with half-life extension and subcutaneous delivery, Bambusa aims to deliver best-in-disease impact across multiple therapeutic areas.

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