- Novartis on Wednesday said its experimental treatment for a disease that causes chronic hives succeeded in the initial part of two Phase 3 studies.
- Researchers tested the drug, remibrutinib, in patients with chronic spontaneous urticaria who didn’t respond well enough to the usual treatment of antihistamines. After 12 weeks, patients in both studies had a meaningful and significant improvement in symptoms without significant side effects, Novartis said. The trials will continue for 52 weeks.
- The results prompted Novartis to start planning for global regulatory submissions in 2024. The company plans to release details from the studies at a medical meeting and expects to share data from the full 52 weeks of research next year.
Remibrutinib is part of a new generation of drugs called BTK inhibitors, which are best known as treatments for blood cancers. Recent research suggests the medicines have promise in a range of conditions, and Novartis is also studying remibrutinib in patients with multiple sclerosis, food allergies, hidradenitis suppurativa and Sjögren’s syndrome.
Despite the promise, trials of the drugs have been mixed. Roche in May announced success in a Phase 2 study of MS patients for its option, called fenebrutinib. But both Sanofi and Merck KGaA have run into liver safety concerns for their BTK inhibitors.
Though Novartis didn’t give detailed data on side effects in its statement Wednesday, the company highlighted that patients had “balanced liver function tests.”
Novartis’s studies, dubbed REMIX-1 and REMIX-2, are identically designed clinical trials that compare remibrutinib against a placebo. Together, they include 925 patients.
People who suffer from chronic spontaneous urticaria currently have few options to treat a disease that can cause debilitating hives and deep tissue swelling. Antihistamines are the first line of defense, but they only help about half of patients. And while Novartis and Roche’s injected biologic treatment Xolair is effective, it’s only reached a relatively small pool of patients, according to the company.
If approved, remibrutinib would offer a “simple and effective” oral option, Novartis said. The potential in the market has also drawn interest from smaller biotechnology companies. Celldex has seen some early success, while signs of liver toxicity derailed an option from Third Harmonic Bio that had been tested in a form of the disease known as chronic inducible urticaria.