BOSTON — Bambusa Therapeutics has dosed the first participant in a Phase 1 clinical trial of BBT002, a next-generation bispecific antibody designed to treat a broad range of inflammatory and immunological conditions. The trial marks the company’s second investigational therapy to enter clinical testing within a year of its founding, underscoring its rapid progress in the biotech space.
BBT002 is engineered as a “platform-in-a-molecule” bispecific antibody, targeting two key inflammatory pathways and offering potential applications across respiratory, dermatological, and gastrointestinal diseases. The ongoing Phase 1 trial (NCT06944925) is a randomized, placebo-controlled study that will assess single and multiple ascending doses in healthy volunteers and adults with chronic obstructive pulmonary disease (COPD). The trial will evaluate safety, pharmacokinetics, tolerability, immunogenicity, and early signals of efficacy. Interim safety and pharmacokinetic results are expected in the first quarter of 2026, with a total of about 96 participants expected to enroll across multiple sites.
Bambusa is also exploring expansion of BBT002’s use into conditions such as asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, eosinophilic esophagitis, and food allergies—further supporting the molecule’s wide-reaching therapeutic potential.
Dr. Thang Ho, Senior Vice President of Development Sciences at Bambusa Therapeutics, emphasized that bringing BBT002 into the clinic within a year of the company’s launch reflects the team’s operational excellence. “BBT002’s dual-target design addresses two core inflammatory mechanisms, which may offer greater efficacy than traditional single-target treatments, especially for patients dealing with complex, multi-organ conditions,” said Ho.
In a parallel announcement, Bambusa confirmed that the U.S. Food and Drug Administration has cleared the company’s Investigational New Drug (IND) application for BBT001, allowing its clinical development to expand beyond Australia into the United States. BBT001 is a bispecific antibody currently under evaluation in a placebo-controlled Phase 1 trial for the treatment of atopic dermatitis and other inflammatory skin conditions. The study includes both healthy volunteers and patients with moderate to severe disease.
With two promising assets now in clinical development and regulatory momentum in both the U.S. and Australia, Bambusa continues to position itself as an emerging leader in biologics for inflammatory and immunological diseases.
