▎WuXiEdited by Kant Content Team

Today, Sanofi announced that its potential "first-in-class" reversible Bruton's tyrosine kinase (BTK) inhibitor rilzabrutinib showed positive results in a Phase 2 study. Analysis revealed,The trial met its primary endpoint, with both high-dose and low-dose oral rilzabrutinib showing efficacy.Occurrence in adult patients with moderate to severe asthmaReduction in the Number of Loss of Asthma Control (LOAC) Events。Detailed trial results were presented at the 2024 American Thoracic Society (ATS) conference. The results support the advancement of rilzabrutinib into Phase 3 trials for further development.

In this proof-of-concept study,At week 12, the relative risk of experiencing an asthma exacerbation event was reduced by 36% (OR: 0.584 [0.253, 1.349]) in patients receiving the high dose and by 25% (OR: 0.570 [0.202, 1.608]) in those receiving the low dose of rilzabrutinib.Patients also experienced a numerically significant and clinically meaningful improvement in asthma symptoms, with the least squares (LS) mean difference in the Asthma Control Questionnaire (ACQ-5) being -0.54/-0.59.Improvement in ACQ-5 was observed as early as Week 2.

Moreover, both high-dose and low-dose rilzabrutinib were well-tolerated, with no occurrences of cytopenia, bleeding events, or atrial fibrillation, and no imbalances in liver function tests.

Rilzabrutinib is an oral, reversible, covalent BTK inhibitor, with the potential to become a "first-in-class" or "best-in-class" treatment for various immune-mediated diseases.BTK enzyme is expressed in B cells and mast cells, playing a crucial role in the processes of various immune-mediated diseases. By applying Sanofi's TAILORED COVALENCY technology, rilzabrutinib can selectively inhibit the BTK target while potentially reducing the risk of off-target side effects.

Rilzabrutinib is one of Sanofi's 12 potential blockbuster drugs.This therapy is currently being studied for multiple indications, including the Phase 3 clinical study for the treatment of immune thrombocytopenia (ITP) announced in April this year.Positive Results, with the relevant regulatory submission expected in the second half of 2024. In February this year, Sanofi announced that the therapy hadPhase 2 TrialSignificantly improved itching, urticaria, and rash symptoms in adult patients with moderate to severe chronic spontaneous urticaria (CSU) in China.

References:

[1] Media Update: New results from rilzabrutinib phase 2 study show potential to be first advanced oral treatment for moderate-to-severe asthma. Retrieved May 23, 2024 from https://www.sanofi.com/en/media-room/press-releases/2024/2024-05-22-17-15-00-2886776

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