Novartis’ remibrutinib shows promise for patients with CSU

Highly selective inhibitor therapy treats patients with chronic spontaneous urticaria

Novartis has shared positive top-line results from two late-stage studies analysing remibrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, among patients with chronic spontaneous urticaria (CSU) whose symptoms are inadequately controlled by H1-antihistamines.

Remibrutinib is a highly selective inhibitor that effectively blocks the BTK cascade and prevents the release of histamines that trigger itches, hives, welts and swelling.

The phase 3 REMIX-1 and REMIX-2 studies duly met their primary endpoint of absolute change from baseline in weekly urticaria activity score (UAS) at week 12, demonstrating clinically significant improvements in disease activity.

Meanwhile, remibrutinib also showed a prompt onset of action, as illustrated by the improvement of UAS at week two in both trials. This data supports the potential of remibrutinib as an effective and fast-acting oral treatment option for those uncontrolled by first-line H1-antihistamines.

Shreeram Aradhye, president of global drug development and chief medical officer at Novartis, was optimistic about the data: “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 use of antihistamines.”

Presently, H1-antihistamines are the first-line treatment in CSU. Around 60% of patients, however, are inadequately controlled with antihistamines alone and continue to live with difficult symptoms.

Individuals currently enrolled in REMIX-1 and REMIX-2 will continue to receive treatment up to week 52 and will also have the opportunity to continue in a long-term extension study. Novartis intends to submit to global health authorities next year.