A novel oral therapy targeting Bruton’s tyrosine kinase (BTK) may offer a new approach for patients with difficult-to-control asthma, according to results from a phase 2 clinical trial.
Exploring a New Asthma Target
Researchers investigated rilzabrutinib, an oral BTK inhibitor, in adults with moderate-to-severe asthma whose symptoms remained uncontrolled despite standard inhaled therapies.
BTK is involved in immune signalling pathways linked to airway inflammation, making it a potential therapeutic target in asthma management.
Symptom Improvements Seen Early
The trial enrolled 196 participants across 13 countries and evaluated two rilzabrutinib doses against placebo over 12 weeks.
Although reductions in loss-of-asthma-control events did not reach statistical significance, patients receiving rilzabrutinib experienced clinically meaningful improvements in asthma symptoms. Benefits were observed as early as week 2 and persisted throughout the study period.
Notably, these improvements continued even after background asthma therapy was gradually withdrawn.
Potential Alternative Mechanism
Researchers suggest the findings may point toward a new treatment mechanism for uncontrolled asthma, particularly for patients who continue to experience symptoms despite existing therapies.
The improvements in asthma control questionnaire scores were significant at both rilzabrutinib doses, supporting further investigation in larger studies.
Safety Profile Remains Encouraging
The most commonly reported side effect was diarrhoea. Importantly, investigators did not observe an increase in infections, a concern sometimes associated with immune-targeting therapies.
Overall safety findings were considered manageable and broadly consistent with previous rilzabrutinib studies.
Looking Ahead
While the study was not powered to definitively demonstrate reductions in asthma-control loss events, the consistent symptom improvements have generated interest in BTK inhibition as a future asthma strategy.
Further trials will now be needed to determine whether rilzabrutinib can deliver sustained clinical benefits and identify which patient groups may respond best.
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