Sanofi releases new data for innovative oral asthma treatment

Oral rilzabrutinib administered at both high dose and low doses provided a numerical reduction in loss of asthma control events and symptomatic improvements, new Sanofi Phase II study data shows.

The clinical trial enrolled adults with moderate-to-severe asthma who are not well controlled on inhaled corticosteroid plus long-acting β2 adrenergic agonist (LABA) therapy.

Key data from the Phase II rilzabrutinib trial

New data from this proof-of-concept study showed that at week 12, high and low doses of the small molecule treatment rilzabrutinib facilitated a 36 percent and 25 percent relative risk reduction in loss of asthma control events, respectively, Sanofi revealed.

Findings were presented at the 2024 American Thoracic Society (ATS) International Conference.

Sanofi stated that the BTK inhibitor rilzabrutinib has the potential to be a best-in-class treatment for several immune-mediated diseases. The company explained that rilzabrutinib can “selectively inhibit the BTK target while potentially reducing the risk of off-target side effects”.

Benefits of the oral therapy

“Many of my patients with asthma who are treated with standard of care inhaled therapies, even those with infrequent asthma attacks, still suffer from asthma symptoms…These patients may not qualify for a biologic medicine today but could benefit from an oral therapy that intervenes earlier in the disease.

“These results are encouraging as they show an improvement in asthma symptoms and a numerical reduction in loss of asthma control events – important parameters in the treatment of this chronic respiratory condition that can significantly impact our patients’ daily lives,” shared Dr Tanya Laidlaw, Director of Translational Research in Allergy Brigham and Women’s Hospital, US.

“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,” commented Houman Ashrafian,
Executive Vice President, Head of Research and Development, Sanofi.

A Phase III programme will evaluate twice-daily dose of rilzabrutinib for moderate-to-severe asthma, Sanofi confirmed.

Further to this data release, earlier this month, Sanofi announced a major manufacturing investment in France, focusing on biologic medicines.