Novartis’ Remibrutinib Improves symptom in chronic spontaneous urticaria

Remibrutinib (LOU064), a Bruton’s tyrosine kinase (BTK) inhibitor, 25 mg twice-daily, was being tested in Novartis‘ Phase III REMIX-1 and REMIX-2 studies on people with chronic spontaneous urticaria (CSU) whose symptoms were not effectively controlled by H1-antihistamines.

Remibrutinib Phase III update:

Both Phase III studies(REMIX-1 and REMIX-2) met their primary endpoint of absolute change from baseline in weekly urticaria activity score (UAS7) at week 12 and demonstrated clinically meaningful and statistically significant improvements in urticaria activity. The studies will continue for week 52. Remibrutinib also indicated an early initiation of effect, as seen by an improvement in UAS7 at Week 2 in the REMIX-1 and REMIX-2 investigations.

These findings confirm remibrutinib’s potential as a new, effective, and fast-acting oral therapy option for patients who have not been managed by first-line H1-antihistamines.

“CSU is a distressing and unpredictable disease, and patients urgently need effective, convenient and well-tolerated treatments that can provide rapid and sustained relief from the relentless itching and deep tissue swelling that greatly impact their daily lives,” said Shreeram Aradhye, M.D., President, Global Drug Development and Chief Medical Officer, Novartis. “These positive top-line results from the Phase III REMIX studies confirm that remibrutinib, a highly selective BTK inhibitor, has the potential to be a first-in-class, oral treatment for people living with CSU whose symptoms are refractory despite use of antihistamines.”

Chronic Spontaneous Urticaria (CSU)

CSU is the medical term for chronic hives that last 6 weeks or longer that are caused by internal rather than exterior allergen exposure. CSU, which affects 40 million people globally, is characterised by itchy hives (wheals) and/or deep tissue swelling (angioedema) on the face, mouth, hands, and feet. Patients may experience burning, stinging, and pain on the skin where hives appear, reducing their quality of life significantly.

In CSU, H1-antihistamines are the first-line treatment. Approximately 60% of individuals are inadequately treated with antihistamines alone and continue to suffer from CSU symptoms. While injectable biologic treatments are a good choice for people whose CSU is controllable by antihistamines, they are used by less than 20% of patients worldwide.

BTK is a histamine-releasing enzyme that, when activated spontaneously, plays a significant part in the debilitating symptoms associated with CSU.

Remibrutinib Mechanism of Action:

Remibrutinib, discovered and developed by Novartis, is a highly selective oral BTK inhibitor with the potential to give quick, sustainable control of CSU within 2 weeks of starting treatment. It maintains a favourable safety profile in a variety of immune-mediated disorders, including multiple sclerosis, hidradenitis suppurativa, and food allergies.

Remibrutinib clinical trial:

Patients presently enrolled in REMIX-1 and REMIX-2 will continue to receive therapy until Week 52, after which they will be eligible to participate in a long-term extension experiment. Novartis plans to share the REMIX findings at an upcoming medical gathering and will begin submitting it to global health authorities in 2024

About REMIX-1 and REMIX-2