Novartis ends Phase III trial of peanut allergy candidate

Novartis and its partner Genentech expect to start a new Phase III trial with an ”optimized dosing” of the drug candidate for patients with food allergies in the third quarter of this year.
Novartis, together with its partner Genentech, has prematurely terminated a Phase III trial of its candidate ligelizumab for the treatment of adult and pediatric patients from 1 year of age with peanut allergy. | Photo: Patrick Sison/AP/Ritzau Scanpix
Novartis, together with its partner Genentech, has prematurely terminated a Phase III trial of its candidate ligelizumab for the treatment of adult and pediatric patients from 1 year of age with peanut allergy. | Photo: Patrick Sison/AP/Ritzau Scanpix

Novartis has prematurely stopped a Phase 3 trial of its candidate ligelizumab to treat 211 adult and pediatric patients aged 1 year and older with allergies to peanuts and at least two other common foods, according to industry publication Endpoints.hhhh

In an email to Endpoints, a Novartis spokesperson wrote that the company expects to start a new phase 3 trial with an ”optimized dosing” of the drug candidate in the third quarter of this year.

Novartis’ candidate, an antibody targeting immunoglobulin E, is still listed on the website under Novartis’ pipeline assets, where it is described as a product candidate for ”food allergy” with an expected launch in 2026 or later.

”As part of an ongoing optimization of ligelizumab clinical programs in food allergy, Novartis has made the decision to stop recruitment and subsequently complete the Phase III study evaluating the efficacy and safety of ligelizumab in food (peanut) allergy,” the Novartis spokesperson said, according to Endpoints.

”This decision was made based on observations from a routine efficacy review that suggested some patients may benefit from an improved dosing schedule. The decision to end the study early is not related to any safety indication,” the spokesperson added.

Denmark’s ALK announced in 2021 an entry into the market for the treatment of food allergies - initially peanuts and tree nuts, including walnut, hazelnut, pistachio.

On Thursday, ALK announced that it has completed and is now expanding a Phase 1 study of a tablet vaccine for peanut allergy.

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