The Swiss pharma’s Phase III trial of ligelizumab in patients with peanut allergies has been terminated, according to a ClinicalTrials.gov update on Tuesday.
Pictured: Novartis building in Basel, Switzerland/iStock, Michael Derrer Fuchs
Novartis appears to be throwing in the towel on its Xolair-successor hopeful. The Swiss pharma’s Phase III peanut allergy trial for ligelizumab has been terminated, according to a ClinicalTrials.gov update Tuesday.
The clinical trials listing does not indicate the reason behind the peanut allergy study termination and the company has yet to make a statement as of this writing. Novartis’ pipeline still lists the asset for food allergy, marked as a lead indication. The pharma had previously projected a market size of greater than $1 billion for its food allergy antibody, according to Endpoints News.
Ligelizumab, a subcutaneous biologic injection, was being tested in both peanut allergy and chronic forms of the skin disease urticaria. In January 2023, a 39-patient Phase III study in chronic inducible urticaria was axed. Two years prior, Phase III flops had the company cutting its intended indication of the drug for chronic spontaneous urticaria (CSU).
Xolair, Novartis’ popular Genentech-partnered treatment for allergic asthma, chronic rhinosinusitis and CSU, has patents set to expire in 2024 and 2025. The companies are potentially closing in on a new indication, which could help stave off the looming patent cliff.
In December 2023, the FDA accepted a supplemental biologics license application and granted priority review to Xolair for food allergies. If approved, it would be the first treatment on the market for allergic reactions to multiple foods due to accidental exposure in patients one year and older. A decision is expected during the first quarter of 2024.
Novartis announced positive Phase III results for its BTK inhibitor in CSU in August 2023. Remibrutinib met its primary endpoint and demonstrated a rapid onset, improving patients’ symptoms in as little as two weeks. The company is anticipating a regulatory submission this year.
Rounding out its immunological portfolio is a priority for Novartis with the impending patent expiration. In 2022, Xolair generated $4 billion in worldwide sales. In the first half of 2023, sales of the drug generated $716 million for Novartis.
Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.
