Novartis has achieved encouraging results in the Phase III trials of remibrutinib, showcasing its effectiveness in managing symptoms of chronic spontaneous urticaria. Both the REMIX-1 and REMIX-2 studies, part of this Phase III endeavor, successfully met their primary and secondary objectives by illustrating substantial enhancements in urticaria disease activity scores. Individuals undergoing treatment with remibrutinib experienced prompt amelioration, with noticeable improvements as early as two weeks after initiating therapy.
Remibrutinib, an orally-administered, highly selective BTK inhibitor, demonstrated a favorable safety profile and well-tolerated attributes. Notably, liver function tests remained balanced in both active and placebo groups across both studies. The conclusive findings, set for submission in 2024 after the final 52-week readout, will be comprehensively shared during upcoming medical conferences. Should it receive approval, remibrutinib could pioneer a novel class of chronic spontaneous urticaria (CSU) treatment, presenting a streamlined and practical option for the 60% of patients who find conventional H1-antihistamines inadequate.
Novartis has disclosed top-line outcomes from the Phase III REMIX-1 and REMIX-2 studies, evaluating remibrutinib 25 mg b.i.d., a Bruton's tyrosine kinase (BTK) inhibitor. These investigations focused on patients grappling with chronic spontaneous urticaria (CSU) that remained uncontrolled despite first-line H1-antihistamine treatment. Both trials fulfilled their primary endpoint by revealing improvements in disease activity through the absolute change from baseline in weekly urticaria activity score (UAS7) at Week 12. The study is set to continue through Week 52. Additionally, remibrutinib showcased its rapid onset of action, exemplified by the improvement of UAS7 at Week 2 in both REMIX-1 and REMIX-2 studies.
Chronic spontaneous urticaria (CSU), a condition characterized by persistent hives that last for over six weeks due to internal factors rather than external allergens, affects a considerable population of 40 million globally. Patients experience itching hives (wheals) and deep tissue swelling (angioedema) that can manifest on various body parts, causing discomfort and adversely impacting their quality of life.
H1-antihistamines constitute the primary approach to CSU treatment, yet around 60% of patients remain insufficiently managed by antihistamines alone, grappling with distressing CSU symptoms. While injectable biologic therapies offer relief for those unresponsive to antihistamines, they are accessed by less than 20% of affected individuals worldwide. BTK, a pivotal enzyme in histamine release, becomes active spontaneously and plays a significant role in the debilitating symptoms associated with CSU.
Developed by Novartis, remibrutinib is a selective oral BTK inhibitor with the potential to provide rapid, sustained CSU control within two weeks of initiation. Participants enrolled in REMIX-1 and REMIX-2 will continue receiving treatment until Week 52, with an opportunity to extend into a long-term follow-up trial.
Novartis plans to present the comprehensive REMIX data during an upcoming medical conference and to submit it to global health authorities starting in 2024. REMIX-1 and REMIX-2, parallel Phase III studies, follow an identical design, enrolling 925 participants globally. These trials aim to ascertain the efficacy, safety, and tolerability of remibrutinib in adults with inadequately controlled chronic spontaneous urticaria, compared to a placebo, using several key outcome measures.