Source – Novartis
Novartis has unveiled promising initial outcomes from the Phase III REMIX-1 and REMIX-2 trials assessing the effectiveness of remibrutinib 25 mg b.i.d., a potent inhibitor of Bruton’s tyrosine kinase (BTK), among patients grappling with chronic spontaneous urticaria (CSU) that remains poorly managed despite treatment with H1-antihistamines. Both Phase III studies have achieved their primary objective of measuring the absolute shift from baseline in the weekly urticaria activity score (UAS7) at the 12-week mark, revealing substantial and statistically significant enhancements in disease control. The investigations are set to continue until the 52-week mark. Notably, remibrutinib has demonstrated rapid action, manifesting as an improvement in UAS7 as early as Week 2 within both the REMIX-1 and REMIX-2 trials. These findings underscore the potential of remibrutinib as a fresh, efficient, and swift-acting oral treatment avenue for individuals for whom standard H1-antihistamines have proven inadequate.
“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. 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.”
– Shreeram Aradhye, M.D., President, Global Drug Development and Chief Medical Officer, Novartis
CSU, a term denoting persistent hives that endure for six weeks or more, is triggered by internal factors rather than external allergen exposure. Affecting 40 million people worldwide, CSU is marked by itchy hives (wheals) and deep tissue swelling (angioedema), often emerging on the face, throat, hands, and feet. The condition can inflict burning, stinging, and discomfort at the hive sites, leading to a significant reduction in quality of life.
H1-antihistamines are the primary line of defense against CSU. However, about 60% of patients experience inadequate symptom control with these drugs and continue to grapple with the distressing manifestations of CSU. While injectable biologic therapies effectively address uncontrolled CSU cases, they are employed by less than 20% of patients worldwide. BTK, a key enzyme linked to histamine release, plays a crucial role in triggering the debilitating symptoms connected to spontaneous CSU.
Developed by Novartis, remibrutinib stands out as a highly selective oral BTK inhibitor that holds promise in achieving swift and sustained control over CSU within two weeks of initiation. Its safety profile remains favorable across various immune-mediated conditions, including multiple sclerosis, hidradenitis suppurativa, and food allergies. Participants currently enrolled in REMIX-1 and REMIX-2 will receive treatment until the 52-week mark and will also have the option to extend their participation in a longer-term trial.
Novartis is gearing up to present the REMIX trial data at an upcoming medical conference and has plans to initiate submissions to global health authorities starting in 2024.
Remibrutinib, a remarkably selective oral inhibitor of Bruton’s tyrosine kinase (BTK), obstructs the BTK pathway, thereby preventing the release of histamine responsible for itchiness, hives, and swelling. In Phase II research, remibrutinib demonstrated rapid onset of action and sustained effectiveness in patients facing moderate to severe chronic spontaneous urticaria (CSU). The Phase III REMIX data now corroborates these results. Beyond CSU, remibrutinib’s potential is being investigated in other immune-mediated disorders like multiple sclerosis, hidradenitis suppurativa, food allergies, and Sjögren’s syndrome. Should it receive approval, remibrutinib could emerge as a valuable oral option alongside Xolair (omalizumab), the sole injectable biologic authorized for CSU. In the United States, Novartis Pharmaceuticals Corporation and Genentech, a member of the Roche Group, are collaborating to develop and jointly promote Xolair.
