New COPD trial doses first participant with dual-target drug BBT002
Study evaluates safety and dosing of bispecific antibody therapy
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The first person with chronic obstructive pulmonary disease (COPD) has now been dosed with BBT002, an experimental medication being developed by Bambusa Therapeutics, in an ongoing Phase 1b clinical trial.
The trial (NCT06944925) is evaluating BBT002’s safety and pharmacological properties against a placebo in up to 98 healthy adults and people with COPD, ages 35 to 75. The study may still be recruiting participants at a study site in Perth, Australia.
The company reported earlier that the first healthy volunteer in the trial was dosed in May 2025, and initial study findings are expected in the second half of the year. Bambusa also indicated that the program may eventually expand to include other lung conditions linked to type 2 inflammation, a form of immune activity often associated with higher levels of eosinophils, a type of white blood cell.
Company advances therapy from healthy volunteers into COPD testing
“Moving BBT002 from healthy volunteers to proof-of-concept studies in just seven months demonstrates the power of our bispecific platform and our ability to execute with urgency while maintaining the scientific rigor required to advance meaningful new options for patients,” Shanshan Xu, MD, PhD, Bambusa’s founder and CEO, said in a company press release.
COPD is a chronic inflammatory lung disease in which the airways become narrowed and damaged over time. People with COPD often experience symptoms such as shortness of breath, wheezing, and coughing with mucus that tend to worsen gradually.
Up to 40% of people with COPD have high levels of eosinophils, immune cells involved in allergic and inflammatory responses. These patients may have type 2 inflammation, a form of immune activity that can contribute to more severe disease.
BBT002 is a bispecific antibody-based therapy designed to simultaneously block two key immune signaling pathways involved in type 2 inflammation — IL-4/IL-13 and IL-5. By targeting both at once, the therapy may suppress inflammation more broadly than single-target biologic therapies such as Nucala (mepolizumab) and Dupixent (dupilumab), according to the company.
Nucala (mepolizumab) works by blocking IL-5 signaling, while Dupixent (dupilumab) blocks IL-4/IL-13 signaling.
Preclinical data show BBT002 blocks two inflammation pathways
In preclinical studies, BBT002 was shown to bind and block both targets simultaneously. The therapy suppressed these pathways to a similar extent as Nucala- and Dupixent-like molecules in cellular models. It also stayed in the body longer than a Dupixent-like molecule in preclinical testing, which suggests the potential for less frequent dosing, according to the company.
In a mouse model of COPD, BBT002 was reported to be as effective as — or in some measures superior to — Dupixent at significantly reducing airway narrowing, eosinophil levels, and other biomarkers of type 2 inflammation. The experimental therapy also reduced inflammatory cells and lung tissue damage in the animals, according to the preclinical data.
The ongoing Phase 1 trial is a placebo-controlled study testing single and multiple ascending doses of BBT002 in healthy volunteers and adults with COPD. Â The main goal is to evaluate safety and tolerability. Researchers are also assessing how the therapy moves through and acts in the body (pharmacokinetics and pharmacodynamics), along with its potential to trigger immune reactions (immunogenicity).
Bambusa is also running a Phase 1/2 study (NCT07288554) of BBT002 in China, which will include up to 68 healthy volunteers and people with COPD. Recruitment may be currently open at only one of the study’s 11 sites.
