Ligelizumab

Alladapt Immunotherapeutics, a well-financed biotech working in the food allergy field, shut down following talks with the FDA, according to a source familiar with the company. After claiming success in a Phase 1/2 trial in June 2023, Alladapt prepared for a Phase 3 of its experimental food allergy drug. Codenamed ADP101, the oral candidate had received the FDA fast track tag for mono- and multi-food allergies. But a late-stage trial proved too financially daunting. The “FDA guidance for the Phase 3 trial made it economically unviable,” according to the source, who confirmed the company closure to Endpoints News on the condition of anonymity. Investors got a “partial recovery on their investment,” the source added. The Menlo Park, CA-based startup was co-founded in 2018 by CEO Ashley Dombkowski and Kari Nadeau, a former Stanford allergist and now chair of the Department of Environmental Health at Harvard School of Public Health. Dombkowski didn’t respond to an Endpoints inquiry. Alladapt disclosed a $119 million funding round in June 2022 and a $50 million loan with Hercules Capital two months later. The biotech disclosed construction of a manufacturing facility on the outskirts of Philadelphia the year prior. The facility was expected to be completed in “late 2024,” according to architecture and engineering firm Genesis. The company’s investors included Patient Square Capital’s Enavate Sciences, Gurnet Point Capital, AllerFund, Red Tree Venture Capital, Novartis and others. Its equipment was listed for auction in July. Rock Creek Advisors, a firm that works on liquidations and restructurings, lists Alladapt as a client on its website. Some of its top executives left this year for posts at Eccogene and Navigator Medicines . The food allergy space has been through a series of ups and downs in recent years. Nestlé’s attempt to market a peanut allergy drug — known as Palforzia, from its $2.6 billion Aimmune acquisition — had failed commercially. There was a major win in February with the FDA approval of Novartis and Genentech’s Xolair for children and adults with one or more food allergies. Novartis had also axed a peanut allergy Phase 3 trial earlier this year, but said it expected to start a new study of the anti-inflammatory, dubbed ligelizumab, later in 2024. With its ADP101 candidate, Alladapt aimed to deliver small bits of protein from the “big nine” food allergies — milk, eggs, wheat, fish, shellfish, peanuts, tree nuts, soy and sesame — so that patients wouldn’t be as sensitized to the allergens. The startup also terminated an open-label extension study this year. Also in the food allergy space are Leaps by Bayer-backed Ukko and Regeneron, which is testing Dupixent combined with its hematology drug linvoseltamab in Phase 1 .

Chronic spontaneous urticaria is a skin condition characterised by persistent, itchy hives that last six weeks or longer. Credit: wisely via Shutterstock. The US Food and Drug Administration (FDA) has accepted for review the resubmitted supplemental Biologics License Application (sBLA) for Sanofi and Regeneron’s Dupixent (dupilumab) in chronic spontaneous urticaria (CSU). The application seeks to expand Dupixent’s use to treat adults and adolescents (aged 12 and older) with CSU inadequately controlled by H1 antihistamine therapy. The FDA’s target decision date is 18 April 2025. Dupixent, a fully human monoclonal antibody, inhibits the signalling of IL-4 and IL-13 pathways and is different from other immunosuppressants used to treat this condition. The resubmission builds on data from the LIBERTY-CUPID Phase III clinical trial (NCT04180488), which included three studies (Study A, Study B, and Study C). The sBLA adds pivotal results from Study C, conducted in biologic-naive patients with uncontrolled CSU who were receiving standard-of-care antihistamines. Study C met both its primary and key secondary endpoints, demonstrating that Dupixent significantly reduced itch and urticaria activity (hives and itch severity), aligning with earlier results from Study A. Safety data across the LIBERTY-CUPID programme were consistent with Dupixent’s established safety profile, with common adverse events including injection site reactions and Covid-19 infections. Dupixent has already been approved for CSU in Japan and the United Arab Emirates (UAE) and is under regulatory review in the European Union. Outside of Japan and the UAE, the safety and efficacy of Dupixent in CSU remain under evaluation. The potential new indication for CSU comes as Regeneron and Sanofi continue to expand Dupixent’s market presence. In September 2024, the FDA approved Dupixent for chronic obstructive pulmonary disease (COPD), marking its sixth indication and making it the first biologic approved for COPD. Dupixent is also approved for conditions including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis. Dupixent generated $11.3bn (€10.7bn) in global sales in 2023, as per Regeneron’s financials. Projections from GlobalData’s Pharma Intelligence Center suggest revenue could reach $23.6bn by 2030. GlobalData is the parent company of Pharmaceutical Technology. CSU is a skin condition characterised by persistent, itchy hives that last six weeks or longer. While antihistamines and anti-inflammatory treatments are used to manage symptoms, there is an unmet need for more effective options in patients with uncontrolled disease. Meanwhile, Novartis is advancing its CSU pipeline with promising data for its investigational drug, ligelizumab. Results from the Phase III study (NCT03907878) released in May 2024 showed that almost half of patients were completely free of itch and hives as assessed at week 52 using urticaria activity scores. Novartis said it plans to submit ligelizumab for regulatory approval in the second half of 2024.