Early Phase IIb data from 66 patients showed Novartis’ BTK inhibitor remibrutinib has potential outside chronic spontaneous urticaria, leading to symptomatic relief in patients with hidradenitis suppurativa.
Pictured: Novartis’ logo outside its building in San Diego, California/iStock, JHVEPhoto
Novartis’ investigational BTK inhibitor remibrutinib may also hold promise for hidradenitis suppurativa, potentially opening another therapeutic area for the candidate beyond its lead indication, according to several media reports.
Over the weekend, at the American Academy of Dermatology annual meeting, Novartis revealed early Phase IIb data from 66 patients who had been treated with either 25 mg or 100 mg of remibrutinib, which was dosed twice-daily, according to Fierce Biotech. The study’s primary endpoint was a 50% decrease in abscesses and inflammatory nodules, along with no increase in draining tunnels compared with baseline.
At 16 weeks, around 73% of patients treated with the 25-mg dose responded to remibrutinib, while the higher dose level was slightly less effective at 49%. By comparison, 34.7% of those in the placebo group reached the primary outcome, according to Endpoints News.
Remibrutinib also outperformed placebo at clearing 50%, 70% and 90% of abscesses and inflammatory nodules, respectively, reported Fierce Biotech. Around 36% of patients in the lower-dose group saw 90% clearance, compared to only 8% of placebo counterparts.
In terms of safety, the mid-stage study flagged five cases of grade three and four adverse events in the remibrutinib group and four grade three toxicities in the placebo arm. One patient given the 25-mg remibrutinib dose was found to have heightened levels of liver enzymes, which could be suggestive of liver damage, though this was ultimately deemed unrelated to the study drug.
Designed to be orally available, remibrutinib is a highly selective and covalent inhibitor of the Bruton’s tyrosine kinase (BTK) protein, which is central to B-cell development and the production of antibodies and cytokines.
Remibrutinib’s lead indication is chronic spontaneous urticaria, an inflammatory skin disease characterized by itchy hives and swelling. In August 2023, Novartis released results from two Phase III studies demonstrating that remibrutinib can significantly improve weekly urticaria activity score through 12 weeks of follow-up.
Novartis is planning to make regulatory filings for remibrutinib in this indication within the year. During its fourth-quarter and full-year 2023 financial report in January 2024, the company named rumibrutinib as one of its key milestones this year that will help it meet its growth target.
If approved, remibrutinib could help the company shore up any revenue losses that will come with the loss of Xolair’s patent protections, some of which are set to expire this year.
In addition to chronic spontaneous urticaria, Novartis is also assessing the potential of remibrutinib in other immune-mediated conditions including chronic inducible urticaria, multiple sclerosis, food allergies and hidradenitis suppurativa.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
