In the quest to reduce loss of asthma control (LOAC) events, oral rilzabrutinib scored well in a recent, 12-week, phase 2 clinical trial. As the Sanofi drug advances to a phase 3 trial, company officials said the future looks promising for the treatment of moderate to severe asthma.
Calling the results a “rapid and clinically meaningful improvement,” rilzabrutinib is a reversible, covalent BTK inhibitor that has the potential to be an effective treatment for several immune-mediated diseases, including immune thrombocytopenia (ITP), asthma, chronic spontaneous urticaria, prurigo nodularis, IgG4-related disease and warm autoimmune hemolytic anemia.
“Advanced oral therapies have the potential to change the treatment paradigm for diseases like asthma, and we remain committed to exploring disruptive mechanisms of action for people living with uncontrolled chronic inflammatory diseases,” said Houman Ashrafian, BM, BCh, PhD, Sanofi executive vice president and head of research and development.
This phase 2 rilzabrutinib clinical trial was a randomized, double-blind, placebo-controlled, parallel-group, 12-week proof-of-concept study. It was designed to assess the efficacy, safety and tolerability of the drug in 64 participants with moderate-to-severe asthma who are not well controlled on inhaled corticosteroid (ICS) plus long-acting β2 adrenergic agonist (LABA) therapy. Researchers tracked two daily doses of rilzabrutinib at 800 mg and 1,200 mg.
The goal of the clinical trial was a reduction in LOAC events. Secondary endpoints included asthma control (measured by the asthma control questionnaire, ACQ-5) and asthma quality of life (measured by the asthma quality of life questionnaire, AQLQ) or lung function (measured by FEV1).
According to the study authors, asthma is one of the most common chronic respiratory diseases affecting millions of people worldwide. Despite standard-of-care treatment, about 50% of patients with asthma remain uncontrolled with a high symptom burden that impacts their quality of life.
