– Bambusa’s lead product candidate, BBT001 is a next-generation long-acting bispecific antibody targeting two clinically and commercially validated targets, IL-4Rα and IL-31 for the treatment of atopic dermatitis (AD) and other type 2 inflammatory skin diseases –
– BBT001 achieved rapid, deep, and sustained effects on key biomarkers of interest in AD for at least 12 weeks, including reduction of TARC and inhibition of pSTAT6 –
– BBT001 was well tolerated across all doses in both the single- and multiple-ascending dose cohorts of the Phase 1 trial –
– BBT001 exhibited a consistent half-life of approximately 33 days in Phase 1 trial supporting prolonged maintenance dosing interval compared to currently approved medicines in AD –
– Bambusa plans to disclose data from the ongoing placebo-controlled, 4-week Phase 1b/2a trial of BBT001 in patients with moderate to severe atopic dermatitis in the middle of 2026 –
BOSTON, April 1, 2026 /PRNewswire/ — Bambusa Therapeutics, Inc. (Bambusa Therapeutics), a clinical-stage biotechnology company advancing next-generation bispecific antibodies for immunology and inflammation, today announced it presented data from the multiple ascending dose (MAD) cohorts of the Phase 1 trial evaluating BBT001 in healthy volunteers at the 2026 American Academy of Dermatology Annual Meeting (AAD 2026) in Denver, Colorado.
The AAD 2026 clinical poster of BBT001 titled, “Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BBT001, a Novel Bispecific IL-4Rα/IL-31 Antibody: Results from the Single- and Multiple-Ascending Dose Portions of a Phase 1 Study of Healthy Volunteers and Patients with Atopic Dermatitis” highlighted the following data:
- % change in Thymus and Activation-Regulated Chemokine (TARC). TARC levels in the blood correlate strongly with disease severity in AD (e.g. Eczema Area and Severity Index [EASI] score).
- BBT001 demonstrated unprecedented dose-dependent, rapid, deep, and sustained reduction in TARC compared to baseline after multiple doses.
- % change in phosphorylated STAT6 (pSTAT6). pSTAT6 is a key downstream mediator of type 2 inflammation in atopic dermatitis.
- BBT001 achieved rapid, complete, and sustained inhibition of pSTAT6 for at least 12 weeks after multiple doses.
- Pharmacokinetics (PK): BBT001 exhibited prolonged PK with a half-life of approximately 33 days at or above target exposure after multiple doses, consistent with the PK observed in the SAD cohorts.
- Safety and Tolerability: BBT001 was well-tolerated across all doses in the SAD cohorts (previously presented at EADV 2025) and MAD cohorts with a clean safety profile observed in the trial.
- Immunogenicity: The incidence of anti-drug antibodies (ADA) was low and showed no apparent impact on safety or PK.
“We were excited to highlight the data from our BBT001 clinical program for the first time at the American Academy of Dermatology Annual Meeting,” said Thang Ho, Ph.D., Chief Scientific Officer at Bambusa Therapeutics. “The Phase 1 MAD data confirm the earlier clinical evidence achieved in the SAD portion of the trial, and further support BBT001’s potential to become a best-in-disease biologic to treat atopic dermatitis. Importantly, these data continue to support the potential for BBT001 to deliver faster onset and improved clinical outcomes for patients with atopic dermatitis compared to currently approved medicines.”
“Following our team’s rapid execution of the BBT001 Phase 1 trial including the presentation of the positive data from all doses and cohorts, we now look forward to disclosing data from our ongoing BBT001 4-week Phase 1b/2a trial in patients with atopic dermatitis in the middle of this year,” said Shanshan Xu, M.D., Ph.D., Founder & Chief Executive Officer of Bambusa Therapeutics. “The possibility to generate our first proof-of-concept clinical data in patients with AD is a significant milestone for Bambusa Therapeutics, and it has the exciting potential to give us the first look of how BBT001 could redefine the standard of care for people with atopic dermatitis in the future.”
BBT001 is currently being evaluated in multiple ongoing Phase 1b/2a trials in patients with moderate to severe AD. The Company expects to disclose data from the ongoing 4-week placebo-controlled trial in the middle of 2026.
About the Phase 1 SAD/MAD trial of BBT001
BBT001-001 is a randomized, placebo-controlled, single- and multiple-ascending-dose study in healthy volunteers and adults with moderate to severe atopic dermatitis. The trial is evaluating safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and preliminary clinical activity.
About BBT001
BBT001 is Bambusa Therapeutics’ lead clinical program and a first-in-class, multi-targeting, half-life extended bispecific antibody engineered to block both IL-4Rα and IL-31 signaling. By addressing type 2 inflammation and directly targeting the pathways that drive itch, BBT001 is designed to provide faster and more durable relief for patients with atopic dermatitis and other inflammatory skin diseases. The molecule has demonstrated a favorable safety profile and strong pharmacokinetics in healthy volunteers, supporting its advancement into multiple clinical trials in patients, including AD and chronic spontaneous urticaria (CSU).
About Bambusa Therapeutics
Bambusa Therapeutics is a clinical-stage biotechnology company developing a portfolio designed to transform care across a wide spectrum of chronic diseases. Powered by an innovative antibody engineering platform featuring half-life extension and high-concentration subcutaneous delivery, Bambusa’s vision is to deliver transformative medicines for patients across every stage of life — setting a new pace for the next era of I&I therapeutics.
- BBT001 is a first-in-class half-life-extended bispecific antibody targeting IL-4Rα and IL-31 with best-in-disease potential. It is currently in Phase 1b/2a proof-of-concept development for atopic dermatitis and other type 2 inflammatory skin diseases.
- BBT002 is a first-in-class half-life-extended bispecific antibody targeting IL-4Rα and IL-5 with platform-in-a-molecule potential. It is currently in Phase 1b proof-of-concept development for type 2 inflammatory disorders including COPD, asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis, and food allergy.
- BBT003 and BBT004 are preclinical programs focused on gastroenterology and rheumatology, respectively.
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