Novartis' Remibrutinib Meets Goals In Chronic Spontaneous Urticaria Trials

(RTTNews) - Novartis AG (NVS) announced on Wednesday positive top-line results from its two late-stage studies evaluating Remibrutinib in patients with chronic spontaneous urticaria, dubbed REMIX-1 and REMIX-2.

REMIX-1 and REMIX-2 are two identically designed global, placebo-controlled phase III studies evaluating the efficacy, safety and tolerability of Remibrutinib 25 mg twice daily in adult participants with chronic spontaneous urticaria that is inadequately controlled by second generation H1-antihistamines compared with placebo. The REMIX-1 trial consists of 470 participants while REMIX-2 consists of 455 participants.

Chronic Spontaneous Urticaria (CSU) is characterized by the abrupt onset of itchy hives (wheals) and/or deep tissue swelling (angioedema) for more than 6 weeks. CSU brings about considerable emotional strain, with a majority of patients dealing with sleep disturbances and high occurrences of psychological conditions like anxiety and depression.

According to the company, the REMIX-1 and REMIX-2 studies met all primary and secondary endpoints, showing rapid, clinically meaningful improvements across urticaria disease activity scores at Week 12. Rapid improvement was observed as early as 2 weeks after treatment initiation with Remibrutinib.

Patients currently enrolled in the REMIX-1 and REMIX-2 trials will continue to receive treatment up to Week 52, and the final 52-week data readout is planned for 2024.

If approved, Remibrutinib has the potential to become the first of a new class of chronic spontaneous urticaria treatment in a decade, offering a convenient and effective alternative for the 60% of patients whose symptoms are not controlled by H1-antihistamines, noted the company.

NVS closed Tuesday's trading at $103.05, up 0.24%.