At week 12, both Phase 3 studies' primary endpoints of absolute change from baseline in the weekly UAS7 were reached, showing statistically significant and clinically meaningful improvements in disease activity
A image of Novartis Campus. (Credit: Novartis AG)
Novartis announced that its remibrutinib 25 mg has met primary endpoints and showed rapid symptom control in Phase III REMIX-1 and REMIX-2 trials of patients with chronic spontaneous urticaria (CSU).
Remibrutinib is a highly selective, oral Bruton’s tyrosine kinase (BTK) inhibitor. It blocks the BTK cascade and stops the release of histamine that roots itch, hives/welts and swelling.
The late-stage REMIX-1 and REMIX-2 studies assessed remibrutinib in CSU patients whose symptoms are not properly controlled by H1-antihistamines, which are said to be the first-line treatment in CSU.
At week 12, both Phase 3 studies’ primary endpoints of absolute change from baseline in the weekly urticaria activity score (UAS7) were reached. This indicated statistically significant and clinically meaningful improvements in disease activity.
According to the Swiss pharmaceutical company, both studies will continue up to week 52 and the enrolled patients will have the option to continue in a long-term extension trial.
In the REMIX-1 and REMIX-2 trials, remibrutinib also indicated a quick onset of action as illustrated by the improvement of UAS7 at week 2.
These findings support remibrutinib’s potential as a new, efficient, and quick-acting oral therapy option for people whose symptoms are not managed by first-line H1-antihistamines, Novartis said.
Novartis chief medical officer and global drug development president Shreeram Aradhye said: “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 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 the use of antihistamines.”
In Phase 2 trials, remibrutinib showed fast onset of action and sustained efficacy in patients with moderate to severe CSU. It was well-tolerated across all doses evaluated in Phase 2.
In addition, the BTK inhibitor is being assessed in other immune-mediated conditions like multiple sclerosis, hidradenitis suppurativa, food allergy and Sjögren’s syndrome.