Remibrutinib could be new effective and fast-acting oral treatment option for chronic spontaneous urticaria: Phase 3 trials
Switzerland: The phase 3 trials REMIX-1 and REMIX-2 have yielded positive top-line results, as announced by Novartis. Trials assessed remibrutinib 25 mg b.i.d., an inhibitor of Bruton’s tyrosine kinase (BTK), in people with a diagnosis of chronic spontaneous urticaria (CSU) and with symptoms not adequately managed through H1-antihistamines.
“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 the use of antihistamines.” Shreeram Aradhye, MD, Novartis's President of Global Drug Development and Chief Medical Officer said in a statement.
The studies successfully met the primary goal of assessing the absolute change from baseline in the weekly urticaria activity score (UAS7) at 12 weeks, suggesting substantial improvements in disease activity that are both statistically significant and clinically meaningful. The trials are also set to continue till the 52-week mark.
In the study, remibrutinib also demonstrated rapid onset of action, as researchers observed an improvement in UAS7 occurring as early as 2 weeks in both the REMIX-1 and REMIX-2 trials.
About 40 million people across the world are estimated to be affected by CSU, a disease characterized by abrupt cases of itchy hives and/or angioedema for a time of over 6 weeks. People ages 20 to 40 years are shown to be commonly affected by the disease, with females being known to experience it almost twice as much as men.
“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,” Aradhye said in a statement.
Previous phase 2 studies have revealed that remibrutinib can exhibit both sustained efficacy and rapid onset of action among patients with moderate-to-severe chronic spontaneous urticaria. The phase 2 trials have shown favourable tolerability across various dose types, and this research has been corroborated by the new REMIX results.
If the drug were to receive approval, it could potentially serve as a complementary oral therapeutic option to omalizumab, a singular injectable biologic known to be authorized for the treatment of CSU.
REMIX-1 and REMIX-2 studies have identical designs and have been performed globally across multiple centres. These randomized, parallel-group, placebo-controlled, double-blind studies comprised 470 participants in REMIX-1 and 455 in REMIX-2.
The studies were conducted to determine the efficacy, safety, and tolerance of remibrutinib among adult patients with inadequately-controlled CSU resistant to second-generation H1-antihistamines, the results were compared with those of a placebo arm.
The primary endpoints of the study were the absolute alteration in the weekly score of urticaria activity from baseline, coupled with the absolute modification of score in hive and itch severity at 12 weeks. Those participants currently included in both trials are allowed the opportunity to continue their treatment through 52 weeks and continue participation in an extended long-term trial.
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