Sanofi’s rilzabrutinib has demonstrated a reduction in itch severity and significantly improved disease activity in adults with moderate-to-severe chronic spontaneous urticaria (CSU), whose symptoms are not adequately controlled by H1 antihistamines.
Results from the phase 2 RILECSU study were presented at the 2024 American Academy of Allergy, Asthma and Immunology Annual Meeting and will form the basis of the phase 3 programme set to begin this year.
CSU is a common and distressing skin condition that causes red, raised, itchy and sometimes painful hives or raised patches on the skin with no obvious trigger.
BTK, expressed in B cells and mast cells, plays a critical role in multiple immune-mediated disease processes.
Using Sanofi’s Tailored Covalency technology, the oral, reversible covalent BTK inhibitor, rilzabrutinib, works by selectively inhibiting the BTK target while potentially reducing the risk of off-target side effects.
Results from the randomised, double-blind study showed that 400mg of rilzabrutinib three times a day demonstrated a significant reduction from baseline in weekly itch severity, urticaria activity and hives severity scores at week 12.
The treatment was generally well tolerated, with no adverse events including cytopenia, bleeding or atrial fibrillation seen with other BTK inhibitors.
Naimish Patel, head of global development, immunology and inflammation at Sanofi, commented: “This data reinforces the potential of rilzabrutinib as a treatment option for patients with moderate-to-severe CSU and we believe that [the treatment] could make a meaningful difference in alleviating the physical and psychosocial burden [that] these patients suffer from.
“Based on this data, later this year we will advance rilzabrutinib into phase 3 development in both CSU and prurigo nodularis, another skin disorder characterised by relentless itching.”
Most recently, Sanofi announced that its investigational anti-CD40L antibody frexalimab had shown potential as a high-efficacy therapy for relapsing multiple sclerosis (MS), a lifelong condition that affects the brain and nerves, based on positive results from a phase 2 study.
The company also announced that it has initiated phase 3 clinical trials of frexalimab in relapsing MS and non-relapsing secondary progressive MS.