Medical name, chronic spontaneous urticaria (CSU), the disease is unpredictable and can cause relentless itching.
Novartis announced yesterday (August 9) results from its phase 3 Remix-1 and Remix-2 studies evaluating remibrutinib 25 mg mg bis in die (twice a day), a Bruton’s tyrosine kinase (BTK) inhibitor, in patients with chronic spontaneous urticaria (CSU) whose symptoms are inadequately controlled by H1-antihistamines.
Clinically meaningful and statistically significant improvements in disease activity showed both phase 3 studies met their primary endpoint of absolute change from baseline in weekly urticaria score (UAS7) at week 12. The UAS7 is a simple scoring system to evaluate urticaria symptoms based on scoring the wheals and itch separately on a scale of 0 to 3 over seven days. The studies will continue until week 52.
Remibrutinib also demonstrated a rapid onset of action as illustrated by the improvement of UAS7 at week 2 in the two studies and these data support the potential of the drug as a new and effective, fast-acting, oral treatment option for those uncontrolled 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, president, global drug development and chief medical officer at Novartis.
“These positive top-line results from the phase 3 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.”
CSU is the medical term for chronic hives that last for 6 weeks or longer, where the underlying cause is internal rather than external exposure to any allergen. In its research, Novartis found it affects 40 million people worldwide, and is characterized by itchy hives (wheals) and/or deep tissue swelling (angioedema), which can occur on the face, throat, hands, and feet. Patients may experience burning, stinging and soreness on the skin where hives occur, causing a severe impact on their quality of life.
The company says that H1-antihistamines are the first-line treatment in CSU2. Approximately 60% of patients are inadequately controlled with antihistamines alone and continue to live with the distressing symptoms of CSU2. While injectable biologic therapies are an effective option for those whose CSU is uncontrolled by antihistamines, less than 20% of patients worldwide are treated with them. BTK is an enzyme central to the release of histamine, and when spontaneously activated plays a critical role in the debilitating symptoms associated with CSU9.
Discovered and developed by Novartis, remibrutinib is a highly selective oral BTK inhibitor and the company says it has the potential to provide rapid, sustained control of CSU within 2 weeks of initiation. It continues to show a favorable safety profile across several immune-mediated conditions including multiple sclerosis, hidradenitis suppurativa and food allergy. Patients currently enrolled in both studies will have the opportunity to continue in a long-term extension trial after reaching week 52.
Novartis will present the Remix data at an upcoming medical meeting and intends to submit to global health authorities starting in 2024.