Remibrutinib potential first-in-class oral treatment for chronic spontaneous urticaria
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Key takeaways:
- Two phase 3 studies achieved the primary endpoint of an absolute change from baseline in weekly disease activity score by week 12.
- Full data will be announced at upcoming medical meetings.
Positive top-line results from two phase 3 studies show remibrutinib yielded statistically significant improvements in disease severity among patients with chronic spontaneous urticaria, Novartis announced in a press release.
According to the release, approximately 60% of patients with chronic spontaneous urticaria (CSU) cannot control their disease with antihistamines alone. Remibrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, has shown that it can be an alternative for patients with CSU whose symptoms are inadequately controlled by H1-antihistamines.
“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,” said Shreeram Aradhye, MD, president of global drug development and chief medical officer at Novartis. “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 use of antihistamines.”
Patients in the REMIX-1 and REMIX-2 studies were administered remibrutinib 25 mg twice daily for 12 weeks.
According to the release, both studies achieved the primary endpoint of an absolute change from baseline in weekly CSU activity score by week 12. Remibrutinib also demonstrated a rapid onset of improvement among patients as early as week 2.
In addition, the drug was well-tolerated with a favorable safety profile.
The studies are ongoing and will continue to evaluate the long-term efficacy of remibrutinib through week 52. Full data will be presented at upcoming medical meetings, according to the release.