Sanofi’s Phase II Trial of Rilzabrutinib Shows Clinically Meaningful Reduction in Loss of Asthma Control


Study results showed a 36% and 25% reduction in loss of asthma control (LOAC) with high and low doses of rilzabrutinib.

Asmathic girl catching inhaler having an asthma attack. Image Credit: Adobe Stock Images/Antonioguillem

Image Credit: Adobe Stock Images/Antonioguillem

Sanofi announced positive results from a Phase II study for rilzabrutinib, a promising first-of-its-kind advanced oral treatment for moderate-to-severe asthma. According to the company, both high and low doses of rilzabrutinib led to a numerical reduction in loss of asthma control (LOAC) events and improvements in symptoms in adult patients with uncontrolled moderate-to-severe asthma. A proof-of-concept study, treatment with high and low doses resulted in a 36% [OR: 0.584 (0.253, 1.349)] and 25% [OR:0.570 (0.202, 1.608)] relative risk reduction in loss of asthma control (LOAC) events, respectively, at week 12, which was the primary endpoint.

Currently, rilzabrutinib is in the process of being studied across multiple indications, such as a Phase III study in ITP and a Phase II study in CSU, both of which yielded promising results and expect to move forward.1

“We are incredibly encouraged by the reduction in loss of asthma control events and improvements in asthma symptoms and look forward to advancing rilzabrutinib into a broader phase III clinical development program to further explore its potential in this disease, said Houman Ashrafian, Head of Research and Development, Sanofi, in a press release. “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.”

According to the Asthma and Allergy Foundation of America (AAFA), 1 in 12 people have asthma in the United States, which equals over 27 million people. It is more common for male children to have asthma. However, this reverses in adulthood, with more women struggling with asthma than men. On average, 10 people die from asthma on a daily basis, and 3,517 people died from it in 2021.2

“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 and their activities are limited because of it,” said Tanya M. Laidlaw, MD, Director of Translational Research in Allergy Brigham and Women's Hospital, Boston, MA, in the press release. “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.”

The American Lung Association stated that in 2016, decreased 41 percent from 1.7 per 100,000 population in 1999 to 1.0. Despite this, progress has slowed. In 2018, 2.2 million children between the ages of 5-17 years old missed over 7.9 million school days, and 10.9 million missed workdays due to asthma among employed adults.3

“Asthma symptoms can be triggered by different things for different people. Allergens, like seasonal pollen, mold spores, dust, or pet dander, are common triggers,” reports AAFA. “Some people also develop asthma symptoms in response to respiratory infections, airway irritants, pollution, weather changes, certain foods, or with exercise.”


1. Media Update: New results from rilzabrutinib phase 2 study show potential to be first advanced oral treatment for moderate-to-severe asthma. Sanofi. May 22, 2024. Accessed May 23, 2024.

2. Asthma Facts. AAFA. Accessed May 23, 2024.,from%2061%25%20to%2043%25).&text=Even%20though%20asthma%20is%20controllable,with%20asthma%20have%20uncontrolled%20asthma.

3. Asthma Trends and Burden. American Lung Association. Accessed May 23, 2024.

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