Pharma Focus Europe

Phase III Trials of Novartis' Remibrutinib Successfully Achieve Primary Endpoints and Indicate Swift Symptom Management in Chronic Spontaneous Urticaria

Wednesday, August 09, 2023

Novartis has revealed positive outcomes from two Phase III trials, REMIX-1 and REMIX-2, which assessed the effectiveness of remibrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, in managing chronic spontaneous urticaria (CSU) patients who exhibit insufficient response to H1-antihistamines. Both studies achieved their primary goal, measuring the absolute change in weekly urticaria activity score (UAS7) from baseline at Week 12. These promising results demonstrated both clinically significant and statistically robust improvements in disease activity. These trials will continue through to Week 52. Notably, remibrutinib exhibited swift onset of action, evident by the improvements in UAS7 as early as Week 2 in both REMIX-1 and REMIX-2 trials.

These findings indicate that remibrutinib may emerge as a novel, efficient, and rapid-acting oral treatment choice for individuals grappling with CSU and facing persistent symptoms despite employing first-line H1-antihistamines. Chronic spontaneous urticaria (CSU) pertains to persistent hives that persist beyond six weeks, attributed to internal factors rather than external allergens. This condition affects millions globally, leading to itchy hives and deep tissue swelling, often culminating in compromised quality of life.

Dr. Shreeram Aradhye, President of Global Drug Development and Chief Medical Officer at Novartis, underscored the pressing need for enhanced treatments for CSU patients. While H1-antihistamines serve as the initial treatment, a significant proportion—approximately 60%—continue to grapple with uncontrolled symptoms. Despite injectable biologic therapies being an option, their adoption remains limited, benefiting fewer than 20% of patients worldwide. Remibrutinib, a selective BTK inhibitor developed by Novartis, promises to effectively manage CSU within two weeks of initiation.

Novartis intends to showcase the REMIX study findings at an upcoming medical gathering and plans to submit the data to global health authorities, commencing the process in 2024.

Remibrutinib, a highly selective oral BTK inhibitor, targets the release of histamine responsible for itchiness, hives, and swelling. It showcased promise in Phase II trials for patients with moderate to severe chronic spontaneous urticaria, displaying a favorable safety profile across various immune-mediated conditions. The Phase III REMIX-1 and REMIX-2 trials are pivotal in investigating remibrutinib's potential in addressing CSU.

These trials, encompassing hundreds of participants each, aim to establish the efficacy, safety, and tolerance of remibrutinib in individuals with chronic spontaneous urticaria that doesn't respond well to second-generation H1-antihistamines. Primary outcomes encompass alterations in urticaria activity, itch severity, and hive severity scores. Participants in these trials have the opportunity to continue treatment in an extended trial until Week 52.

All in all, the Phase III REMIX trial results bring hope for a fresh treatment avenue for individuals with CSU who experience uncontrolled symptoms despite existing therapies.

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