Press release: Phase II results show that rilzabrutinib can quickly reduce the severity of itching caused by chronic spontaneous urticaria and significantly improve disease activity in adults – 02/24/2024 at 3:51 p.m.

Phase II Results Show Rilzabrutinib Rapidly Reduces Severity of Itching Caused by Chronic Spontaneous Urticaria and Significantly Improves Disease Activity in Adults

  • Breaking data presented at the 2024 AAAAI Congress shows that rilzabrutinib, an oral BTK inhibitor, significantly reduces the ISS7 score (weekly pruritus intensity score), from the first week of treatment , in adults with moderate to severe UCS.

  • These data form the basis of phase III programs in the treatment of UCS and prurigo nodularis, which will begin in 2024.

  • Results from pivotal Phase III trials in the treatment of immune thrombocytopenia and Phase II trials in asthma, IgG4 disease and autoimmune hemolytic anemia are expected in 2024.

  • Rilzabrutinib is one of 12


    potential of Sanofi’s cutting-edge immunology development portfolio.

Paris, February 24, 2024

. Positive results from the Phase II RILECSU study show that rilzabrutinib significantly relieves itching and urticaria in adults with moderate to severe chronic spontaneous urticaria (CSU), whose symptoms are inadequately controlled with antihistamines. H1. These results were presented today in the form of a poster at the 2024 Congress of the

American Academy of Allergy, Asthma and Immunology

(AAAAI) which is held in Washington, DC and forms the basis of the Phase III program which is expected to begin in 2024.

Dr. Marcus Maurer

Professor, Dermatology and Allergy, General Director of the Institute of Allergology, La Charité, Berlin

“People with CSU experience disabling symptoms, such as recurrent hive patches that cause intense itching or swelling, or both, which can have a significant impact on their daily lives. These data are promising for patients who cannot be controlled with conventional antihistamines – the ability to quickly control the itch with an oral medication would be an important advance in the treatment of this disease. »

Dr Naimish Patel

Global Head, Development, Immunology and Inflammation, Sanofi

“These data support the therapeutic potential of rilzabrutinib for patients with moderate to severe UCS. We believe that rapid improvement in pruritus could make an important difference and alleviate the physical and psychological burden on these patients. Armed with this data, we will move later this year to phase III of the development of this drug for the treatment of UCS, but also of prurigo nodularis, another skin disease characterized by incessant itching. This year, we also look forward to further results regarding rilzabrutinib, which may illustrate its potential impact on multiple immune diseases. »

Principle results

In this dose-finding study, different doses of rilzabrutinib were evaluated: 400 mg every evening, 400 mg twice a day, and 400 mg three times a day.

In the intention-to-treat (ITT) population, which included patients who had never been treated with omalizumab or had an incomplete response to this drug, rilzabrutinib 400 mg three times daily observed the following:

  • A significant reduction in the ISS7 score (severity score of pruritus, one of the main symptoms of the disease) at week 12, compared to the score at inclusion [moyenne des moindres carrés, respectivement -9,58 contre -6,31; p=0,0181]. Significant variations in the ISS7 score were observed from the first week of treatment.

  • A significant reduction in the UAS7 score (weekly urticaria activity score) at week 12, compared to the score at inclusion [moyenne des moindres carrés, respectivement -17,95 contre -11,20 ; p=0,0116].

  • A significant reduction in the HSS7 score (weekly urticaria severity score) at week 12, compared to the score at inclusion [moyenne des moindres carrés, respectivement -8,31 contre -4,89 ; p<0,0100].

Rilzabrutinib was generally well tolerated, with no cytopenia, bleeding, or episodes of atrial fibrillation, as is the case with other BTK inhibitors. The most frequently observed treatment-related adverse events in patients treated with rilzabrutinib, compared to placebo, were: diarrhea (29.3% 3 times daily and 2 times daily, 7.9% every evening, 15% placebo), nausea (19.5% 3 times a day, 17.1% 2 times a day, 13.2% every evening, 5.0% placebo), headache (9.8% 3 times per day, 14.6% 2 times daily, 5.3% every evening, 0.0% placebo) and abdominal pain (0.0% 3 times daily, 12.2% 2 times daily, 2, 6% every evening, 5.0% placebo).

Rilzabrutinib is currently undergoing clinical studies and no regulatory authority has yet evaluated its safety and efficacy profiles.

About chronic spontaneous urticaria

Chronic spontaneous urticaria (CSU) is an inflammatory skin disease resulting primarily from activation of cutaneous mast cells, which causes recurrent urticarial plaques and pruritus or edema, or both. UCS is usually treated with H1 antihistamines and biologic medications. However, almost 50% of patients remain uncontrolled and have access to only a limited number of other therapeutic options. They continue to experience symptoms that can be disabling and have significant negative effects on their quality of life.

About the RILECSU study

RILECSU is a 52-week Phase II study, comprising a 12-week randomized, double-blind, placebo-controlled period of dose finding and assessment of efficacy and safety, followed by ‘an open-label extension period of 40 weeks.

The RILECSU study is being conducted to evaluate rilzabrutinib in adults with moderate to severe UCS who remain symptomatic despite treatment with anti-H1 antihistamines and who have never been treated with omalizumab or have had an incomplete response. to this medicine. The primary endpoint was the change in ISS7 score (weekly pruritus severity score) at week 12, compared to the score at inclusion. Secondary endpoints included changes in weekly UAS7 AND HSS7 scores at week 12 from baseline.

Trial participants (n=160) were randomized 1:1:1:1 to receive rilzabrutinib 400 mg every night or 400 mg twice daily or 400 mg three times daily or one placebo.

About rilzabrutinib

Rilzabrutinib is an oral, reversible, covalent BTK inhibitor that has the potential to be first or best in class pharmacotherapeutics for the treatment of several autoimmune diseases. BTK, expressed in B cells and mast cells, plays an essential role in several autoimmune disease processes. Thanks to TAILORED COVALENCY technology


from Sanofi, rilzabrutinib can selectively inhibit the BTK target while potentially reducing the risk of off-target adverse effects.

About Sanofi

We are an innovative, global health company driven by a purpose: pursuing the miracles of science to improve people’s lives. Our teams, present in around a hundred countries, are working to transform the practice of medicine to make the impossible possible. We provide therapeutic solutions that can change the lives of patients and vaccines that protect millions of people around the world, guided by the ambition of sustainable development and our social responsibility.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.

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