Remibrutinib Demonstrates Potential in Early Hidradenitis Suppurativa Trial

Novartis's experimental BTK inhibitor, remibrutinib, has shown potential in treating hidradenitis suppurativa, a skin condition, according to recent media reports. The drug may offer a new treatment avenue beyond its primary indication.

At the American Academy of Dermatology's annual gathering, Novartis presented early Phase IIb data on 66 patients who received 25 mg or 100 mg of remibrutinib twice daily. The main goal was a 50% reduction in abscesses and nodules and no increase in draining tunnels from the start.

After 16 weeks, approximately 73% of the 25-mg group responded positively to remibrutinib, while the higher dose was less effective at 49%, compared to 34.7% in the placebo group. The drug also outperformed the placebo in clearing abscesses and nodules by 50%, 70%, and 90%.

In the lower-dose group, about 36% of patients achieved a 90% clearance, whereas only 8% in the placebo group did. The study identified five cases of severe adverse events in the remibrutinib group and four in the placebo group. One patient had elevated liver enzymes, which could indicate liver damage, but this was not linked to the drug.

Remibrutinib is an oral, highly selective BTK inhibitor, crucial for B-cell development and antibody and cytokine production. Its primary target is chronic spontaneous urticaria, characterized by hives and swelling. In August 2023, Novartis reported that remibrutinib significantly improved urticaria activity scores in two Phase III trials.

Novartis aims to submit regulatory filings for remibrutinib in this area within the year. The drug is also being studied for other conditions, including chronic inducible urticaria, multiple sclerosis, food allergies, and hidradenitis suppurativa. Approval could offset revenue losses from expiring Xolair patents.

The company is also exploring remibrutinib's potential in immune-mediated diseases, with regulatory submissions expected soon. Approval could mitigate the impact of expiring patent protections on Xolair's revenue.