ALK To Present Positive Phase II Data On Its Tablet For The Treatment Of Peanut Allergy At ACAAI 2026

(MENAFN- GlobeNewsWire - Nasdaq) ALK will present phase II data from the ALLIANCE trial of its once-daily investigational sublingual immunotherapy (SLIT) tablet for peanut allergy^1,2,3 at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting in Phoenix, Arizona from 12 to 16 November 2026. The trial included 150 patients aged 4–65 years and evaluated two doses of the tablet compared with placebo.

Key findings being presented include:

• The ALLIANCE phase II trial demonstrated proof-of-concept after only six months of maintenance treatment and efficacy was observed across all age groups in the study.
• Treatment with the peanut tablet was well-tolerated in the study. Treatment-related discontinuations were low. No reports of treatment-related anaphylaxis or treatment-related serious adverse events.

Product Theater: Friday 13 November, 2:35-3:00 PM MT, Product Theater 4
Peanut SLIT-Tablet: A New Frontier in Peanut Allergy Management

Dr. Edwin Kim and Prof. Aikaterini Anagnostou will present recent data from the ALLIANCE trial on the peanut SLIT-tablet and provide insights into the mechanism of action of SLIT in food allergy.

Dr. Jacob Glenting, EVP of Global R&D at ALK, says:

“We're excited to share the results from the ALLIANCE trial at ACAAI. ALLIANCE provided our first clinical proof of concept for the once-daily sublingual immunotherapy ('SLIT') tablet in food allergy. Peanut allergy is a constant presence in the daily life of many patients and their families, and treatment options remain limited. These data give us real momentum as we advance our investigational peanut tablet into phase III, with the goal of offering a sublingual immunotherapy tablet option.”

Dr. Edwin Kim, Division Chief, Pediatric Allergy and Immunology at the University of North Carolina and the principal investigator in the ALLIANCE trial, says:

“We saw a clear dose response in the amount of peanut protein that patients could tolerate after only six months of maintenance treatment, with no treatment-related anaphylaxis or serious adverse events reported. Phase III will be important to build on these results and to understand whether longer treatment can improve response to this once-daily sublingual immunotherapy tablet.”

Scientific Programme
The data are being presented in the following abstracts:

Abstract Title	Presenting Author	Abstract ID ePoster ID	Presentation Details
Efficacy Of The Peanut Sublingual Immunotherapy Tablet In A Phase II Trial	Dr. Edwin Kim	Abstract ID: 8070 ePoster ID: R258	Friday 13 November 4:35-4:50 PM (MT) Monitor 22
Peanut Sublingual Immunotherapy Tablet Was Well Tolerated In A Phase II Trial	Dr. Anna Nowak-Wegrzyn	Abstract ID: 8096 ePoster ID: R252	Friday 13 November 3:05-3:20 PM (MT) Monitor 22
Immunologic Responses Of Peanut-Allergic Individuals To A Peanut Sublingual Immunotherapy Tablet	Dr. Edwin Kim	Abstract ID: 8095 ePoster ID: R250	Friday 13 November 2:35-2:50 PM (MT) Monitor 22

ALK-Abelló A/S

For further information, please contact:

Media: Maiken Riise Andersen, tel. (Denmark) +45 5054 1434
Investor relations: Per Plotnikof, tel. (Denmark) +45 4574 7527, mobile +45 2261 2525

About peanut allergy
Peanut allergy is an IgE-mediated food allergy in which ingestion of peanut proteins triggers immediate hypersensitivity symptoms and can cause anaphylaxis; it typically begins in early childhood and often persists into later life⁴. It is often a severe and potentially life-threatening condition, which accounts for one of the highest rates of anaphylaxis within food allergies^5,6. More than 10 million people in Europe, the USA, and Canada have peanut allergy, more than 3 million of these are children and adolescents^7,8,9. Currently, there are only limited treatment options available, and for some of these patients, sublingual allergy immunotherapy tablets may become a future relevant treatment option with the potential to improve quality of life, both for themselves and their families.

About the ALLIANCE trial
Initiated in 2022, the ALLIANCE trial was designed to assess the tolerability, safety and efficacy of an up-dosing regimen with a once-daily peanut SLIT-tablet in adults, adolescents, and children. The trial was a phase I-II, multi-site trial conducted in North America, with 216 enrolled participants with peanut allergy confirmed by screening via a double-blind, placebo-controlled food challenge. The first part of the trial aimed at determining the starting dose of the up-dosing regimen and the second part aimed at assessing safety and tolerability of the up-dosing regimen as well as gathering early data on its biological action. The third part (phase II) investigated safety and efficacy of selected doses of the peanut SLIT-tablet compared with placebo. The ALLIANCE trial marked the formal start of ALK's clinical development of a novel food allergy treatment which uses the same technology as ALK's SLIT-tablets for respiratory allergies.

About ALK
ALK is a global specialty pharmaceutical company focused on allergy. ALK's activities cover the entire value chain of developing, sourcing, producing, and marketing a diversified portfolio of products for diagnosing and treating respiratory allergies and severe allergic reactions (anaphylaxis) in both children and adults. Headquartered in Denmark, ALK employs around 2,800 people worldwide and is listed on Nasdaq Copenhagen (Nasdaq: ALK B). Visit us at .

Forward-looking statements
This release contains forward-looking statements concerning the development of ALK's investigational peanut SLIT-tablet, including planned clinical studies and its potential future therapeutic role. These statements reflect current expectations and are subject to risks and uncertainties. Future clinical results may differ from the phase 2 findings, and there can be no assurance that the product will receive regulatory approval or become commercially available.

References

1. Kim E, Upton J et al. Efficacy Of The Peanut Sublingual Immunotherapy Tablet In A Phase II Trial. Poster presentation at the American College of Allergy, Asthma & Immunology (ACAAI) 2026; 12-16 November 2026, Phoenix, Arizona. Abstract 8070.
2. Nowak-Wegrzyn A, Anagnostou A et al. Peanut Sublingual Immunotherapy Tablet Was Well Tolerated In A Phase II Trial. Poster presentation at the American College of Allergy, Asthma & Immunology (ACAAI) 2026; 12-16 November 2026, Phoenix, Arizona. Abstract 8096
3. Kim E, Chinthrajah S et al. Immunologic Responses Of Peanut-Allergic Individuals To A Peanut Sublingual Immunotherapy Tablet. Poster presentation at the American College of Allergy, Asthma & Immunology (ACAAI) 2026; 12-16 November 2026, Phoenix, Arizona. Abstract 8095
4. Fleischer, David M.; Conover-Walker, Mary Kay; Christie, Lynn; Burks, A. W.; Wood, Robert A. (2003): The natural progression of peanut allergy: Resolution and the possibility of recurrence. In J. Allergy Clin. Immunol. 112 (1), pp. 183–189. DOI: 10.1067/mai.2003.1517.
5. Cianferoni, Antonella; Muraro, Antonella (2012): Food-induced anaphylaxis. In Immunol. Allergy Clin. North Am. 32 (1), pp. 165–195. DOI: 10.1016/j.iac.2011.10.002.
6. Pouessel, Guillaume; Beaudouin, E.; Tanno, Luciana K.; Drouet, Martine; Deschildre, Antoine; Labreuche, Julien; Renaudin, Jean-Marie (2019): Food-related anaphylaxis fatalities: Analysis of the Allergy Vigilance Network® database. In Allergy Eur. J. Allergy Clin. Immunol. 74 (6), pp. 1193–1196. DOI: 10.1111/all.13717.
7. Grabenhenrich L, Trendelenburg V, Bellach J, et al. Frequency of food allergy in school-aged children in eight European countries-The EuroPrevall-iFAAM birth cohort. Allergy. 2020; 75: 2294–2308
8. Gupta RS, Warren CM, Smith BM, Blumenstock JA, Jiang J, Davis MM, Nadeau KC. The Public Health Impact of Parent-Reported Childhood Food Allergies in the United States. Pediatrics. 2018 Dec;142(6):e20181235. doi: 10.1542/peds.2018-1235. Epub 2018 Nov 19. Erratum in: Pediatrics. 2019 Mar;143(3):e20183835. doi: 10.1542/peds.2018-3835. PMID: 30455345; PMCID: PMC6317772.
9. Gupta, Ruchi S.; Warren, Christopher M.; Smith, Bridget M.; Jiang, Jialing; Blumenstock, Jesse A.; Davis, Matthew M. et al. (2019): Prevalence and Severity of Food Allergies Among US Adults. In JAMA network open 2 (1), e185630. DOI: 10.1001/jamanetworkopen.2018.5630.

Attachment

• ALK ACAAI press release_final_121126

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