Clinical efficacy and tolerability for allergen specific immunotherapy (AIT) with Itulazax (birch pollen extract tablet) is well established.
Allergen challenges are used by clinicians to confirm correct diagnosis and by researchers to evaluate the efficacy of different interventions, eg. AIT. The challenge is performed by using a specific controlled administration schedule of an allergen product in the shock organ (nose, eye, or airway) and then monitor the result. Nasal Allergen Challenge (NAC) is the most common allergen challenge used.
Aquagen SQ (birch pollen extract) has since decades been golden standard for this purpose, but production of this product ended 2019. Clinicians as well as researchers are now in need for an alternative product.
To evaluate a new method for NAC would be of value from a clinical- and research perspective. From a Nordic perspective a NAC study with dissolved Itulazax would be of special interest since birch allergy is a dominant allergen in the region. In a recently published article it was shown that dissolved Grazax and Aquagen Phleum pratense gave comparable result used in grass allergic patients. Therefore, it seems reasonable to assume that the same method could be used with dissolved Itulazax.
The aim of this clinical trial is to evaluate the feasibility of nasal allergen challenge tests with dissolved Itulazax tablets. The main benefit of this proposal is that the allergen composition of the provocation test product is the same as the final product to be treated with. This is likely to increase the treatment motivation of the patient. In addition, the dissolving process is easier for the physician compared to the dissolving of the previously used Aquagen.

Start Date01 Feb 2023

Sponsor / Collaborator

Karolinska Institutet

NCT01675791

/ CompletedPhase 2

A Dose-response Evaluation of ALK Tree AIT

The primary aim of this trial is to evaluate the dose-response relationship for the ALK tree AIT administered once daily in order to define a dose-range that would be suitable for at-home administration.

Start Date01 Aug 2012

Sponsor / Collaborator

ALK-Abello A/S

NCT01500642

/ CompletedPhase 3IIT

Comparison of the Efficacy and the Safety of Different Schedules of Administration of Sub-lingual Immunotherapy in Patients With Ragweed Pollinosis: a Phase III Randomized and Controlled Clinical Study

The dose and the mode of administration of sublingual therapy remain open questions to determine the efficacy and safety of this desensitization therapy, the main purpose of this study is to evaluate if different routes of administration (oral-vestibular vs. sublingual) and a maximum dose of allergen administered are able to determine a different effect or a different incidence of side effects of the therapy in a group of patients with rhinoconjunctivitis and/or asthma due to ragweed

Start Date01 Jun 2011

Sponsor / Collaborator

ASST Fatebenefratelli Sacco

[+1]

100 Clinical Results associated with Birch pollen allergy vaccine(ALK-Abello A/S)

100 Translational Medicine associated with Birch pollen allergy vaccine(ALK-Abello A/S)

100 Patents (Medical) associated with Birch pollen allergy vaccine(ALK-Abello A/S)

Literatures (Medical) associated with Birch pollen allergy vaccine(ALK-Abello A/S)

01 Jan 2025·The Lancet Regional Health - Europe

Efficacy and safety of SQ house dust mite sublingual immunotherapy-tablet (12 SQ-HDM) in children with allergic rhinitis/rhinoconjunctivitis with or without asthma (MT-12): a randomised, double-blind, placebo-controlled, phase III trial

Article

Author: Novakova, Silviya ; Østerdal, Anne Sofie ; Foss-Skiftesvik, Majken Hougaard ; Emeryk, Andrzej ; Gagnon, Remi ; Caimmi, Davide ; Nolte, Hendrik ; Schuster, Antje ; Mikler, Jan ; Pfaar, Oliver

BackgroundAllergic rhinitis/rhinoconjunctivitis (AR/C) induced by house dust mites (HDM) often begins in childhood and negatively impacts a child's quality of life. The daily burden can be further compounded by comorbid asthma. Allergen immunotherapy is the only available treatment targeting the underlying cause of allergic disease. Efficacy and safety of the SQ HDM sublingual immunotherapy (SLIT)-tablet has been demonstrated in adults and adolescents with HDM AR/C with or without asthma, but data are lacking for younger children.MethodsPhase III, randomised, double-blind, placebo-controlled trial in younger children (5-11 years) with HDM AR/C with or without asthma. Eligible subjects were randomised 1:1 to SQ HDM SLIT-tablet or placebo for ∼1 year and had free access to AR/C symptom-relieving medications. The primary outcome was the total combined rhinitis score (TCRS) during the final 8 weeks of the treatment period (∼1 year). Secondary outcomes included the rhinitis daily symptom score (DSS) and medication score (DMS), the rhinoconjunctivitis total combined score (TCS), and the Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) score. Efficacy analyses were conducted on the full analysis set (observed cases). Asthma-related outcomes were also explored. The trial was registered on ClinicalTrials.gov: NCT04145219 and EudraCT: 2019-000560-22.FindingsA total of 1460 subjects were randomised to SQ HDM SLIT-tablet (n = 729) or placebo (n = 731). The primary outcome, TCRS, was statistically significantly different for SQ HDM SLIT-tablet (n = 693) versus placebo (n = 706), with an absolute difference of 1.0 (95% CI: 0.5, 1.4; p < 0.0001) corresponding to a relative reduction of 22.0% (95% CI: 12.0, 31.1). Key secondary outcomes (DSS, DMS, TCS, PRQLQ) showed statistically significant reductions in symptoms and medication use, and improved disease-related quality of life for SQ HDM SLIT-tablet versus placebo. Improvements in asthma symptoms and reduced asthma medication use indicated an additional effect of SQ HDM-SLIT tablet versus placebo. The SQ HDM SLIT-tablet showed a higher event rate for treatment-related adverse events (AEs) than placebo. Most events were of mild or moderate severity and few subjects discontinued due to AEs (2.5%).InterpretationThe trial confirmed the efficacy and safety of the SQ HDM SLIT-tablet for treating HDM AR/C in younger children (5-11 years) with or without asthma. The safety profile supports daily self-administration of the SQ HDM SLIT-tablet in children.FundingALK-Abellό, Hørsholm, Denmark.

01 May 2024·Clinical and Translational Allergy

Utility of silver birch and house dust mite extracts derived from licensed sublingual tablets for nasal allergen challenge

Article

Author: Gil, Ana Jimenez ; Olivieri, Bianca ; Scadding, Guy ; Durham, Stephen R ; Stoenchev, Kostadin

AbstractBackgroundNasal allergen challenge (NAC) is used to investigate the effects of allergen exposure and assess treatment efficacy in allergic rhinitis (AR). This study aims to establish dose‐responses to NAC using licensed silver birch (SB) pollen and house dust mite (HDM) sublingual tablets as sources of the allergen extracts in participants with AR.MethodsSixteen volunteers with HDM‐induced perennial AR and 15 volunteers with SB pollen‐induced seasonal rhinitis underwent a graded up‐dosing NAC with extracts derived from HDM allergen (Acarizax®) and SB (Itulazax®) tablets, respectively. Total nasal symptom score (TNSS, range 0–12) and peak nasal inspiratory flow (PNIF) were recorded before, at 10 min and at the end of the NAC. The dose of each allergen that provoked a TNSS of at least 7 (“provoking dose 7”) in most allergic participants was identified. NACs using the “provoking dose 7” were performed on 5 non‐allergic individuals to test for irritant effects. The “provoking dose 7” of HDM extract was used in a subgroup of two SB allergic, non‐HDM allergic, volunteers, and vice versa for SB extract, to test for allergen specificity of the responses.ResultsMost patients experienced a TNSS of at least 7/12 at a median concentration of 1500 AU/mL for both SB pollen and HDM. The average decline in PNIF at this dose was 63.15% for SB and 63.99% for HDM. NACs using the 1500 AU/mL concentrations were performed on 5 non‐allergic individuals with no symptomatic or PNIF response. 1500 AU/mL of HDM extract produced no symptoms in SB allergics nor 1500 AU/mL SB extract in HDM allergics.ConclusionFor both SB and HDM extracts, the optimal allergen dose for NAC to cause a moderate‐severity response (“provoking dose 7/12”) was 1500 AU/mL. Licensed sublingual allergen tablets provide a readily available and inexpensive source of SB and HDM extracts for use in future interventional studies in AR.

01 Nov 2022·Clinical and Translational Allergy

ITULAZAX^® versus Alutard SQ^® in the treatment of allergic rhinitis induced by pollen from the birch homologous group: A cost‐minimization modeling analysis from the Danish societal perspective

Article

Author: Brandi, Henrik ; Rønborg, Steen M. ; Grand, Tobias Sydendal ; Pollock, Richard F.

AbstractBackground and aimsAllergic rhinitis (AR) is an inflammatory disorder triggered by an allergic immune response to inhaled allergens. Birch pollen is the major allergenic tree pollen in parts of Europe. ITULAZAX® is a sublingual immunotherapy tablet for the treatment of adults with moderate‐to‐severe AR and/or conjunctivitis induced by pollen from the birch homologous group. The aim was to compare the costs of treating AR with ITULAZAX® versus subcutaneous ALUTARD SQ® Betula verrucosa (ALUTARD SQ®) from a Danish societal perspective.MethodsA cost‐minimization model was developed to capture costs of allergy immunotherapy (AIT), interactions with healthcare professionals (HCPs) in three different care settings (general practice, allergy specialist, and hospital), and indirect costs arising from absenteeism and presenteeism. The cost‐minimization analysis was conducted over a 3‐year time horizon with costs reported in 2021 Danish Kroner (DKK) and Euros (EUR) based on the European Central Bank 365‐day average exchange rate. One‐way sensitivity analyses were performed.ResultsThe base case analysis showed that the total cost of treatment over 3 years was estimated to be DKK 49,117 (EUR 6598) per patient with ALUTARD SQ®, compared with DKK 30,996 (EUR 4164) with ITULAZAX®, reflecting a cost saving of DKK 18,121 (EUR 2434) per patient with ITULAZAX® over 3 years. Over the 3‐year time horizon, costs of AIT were predicted to increase by DKK 17,928 (EUR 2408) with ITULAZAX®, while costs of interactions with HCPs were predicted to decrease by DKK 22,528 (EUR 3027) versus ALUTARD SQ®, more than offsetting the increased cost of ITULAZAX®.ConclusionsGiven the equivalent effectiveness of the two AIT products, and the cost savings with ITULAZAX® versus ALUTARD SQ® from a Danish societal perspective, ITULAZAX® should be considered as a cost‐saving alternative to ALUTARD SQ® for the treatment of birch pollen‐induced moderate‐to‐severe AR in adults.

News (Medical) associated with Birch pollen allergy vaccine(ALK-Abello A/S)

23 Apr 2025

·ir.alk.net

ITULAZAX® tree pollen tablet approved for treatment of children in Europe

ALK (ALKB.DC / OMX: ALK B) today announced that its European regulatory filing for ITULAZAX® (tree pollen sublingual allergy immunotherapy tablet) for treatment of young children and adolescents aged five to 17 has been approved by the health authorities in 17 EU countries via a type II variation procedure. First market introductions are expected to follow in the coming months ahead of the 2025/2026 initiation season for new patients starting treatment on pollen allergy tablets. Executive Vice President of R&D, Henriette Mersebach (MD), says: “We are very pleased with the European health authorities' approval which allows us to provide this important treatment option to children and adolescents whose lives are impaired by uncontrolled tree pollen-induced respiratory allergy. Today’s approval marks another significant milestone in our continuous efforts to make our respiratory tablets available to all age groups in all relevant markets". ALK’s regulatory filing was based on data from the TT-06 clinical trial. TT-06 was a randomised, placebo-controlled Phase 3 trial involving 952 children and adolescents aged five to 17 with a clinical history of moderate to severe allergic rhinitis and/or conjunctivitis induced by pollen from birch trees and other trees in the birch homologous group. The trial confirmed that the treatment was well tolerated and had a favourable safety profile. The peer-reviewed results were published in 2024 in the European Journal of Allergy and Clinical Immunology. The tree tablet, branded ITULAZAX® in Europe and ITULATEK® in Canada, has, until now, been approved by 22 countries for adult patients aged 18 to 65. Corresponding paediatric regulatory reviews are currently ongoing in Canada, Switzerland, and the UK. These reviews are expected to complete in 2025. The approval of ITULAZAX® for paediatric use marks the completion of ALK's decade-long development efforts, ensuring that five of the most common respiratory allergies (grass pollen, house dust mite, ragweed pollen, Japanese cedar pollen, and now tree pollen) are all covered by allergy immunotherapy tablets approved for children, adolescents, and adults in relevant markets. The approval is not expected to affect ALK’s financial outlook for 2025. ALK-Abelló A/S For further information please contact: Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525 Media: Maiken Riise Andersen, tel. +45 5054 1434 About ALKALK is a global specialty pharmaceutical company focused on allergy and allergic asthma. ALK manufactures and markets allergy immunotherapy (‘AIT’) treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,800 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net. Attachment Company release_08_25UK_230425_Itulazax_approval_children

Phase 3ImmunotherapyDrug ApprovalClinical Result

27 Feb 2025

·ir.alk.net

FDA approves ODACTRA® for the treatment of house dust mite allergy in young children

ALK (ALKB:DC / OMX: ALK B) today announced that the US Food and Drug Administration (FDA) has approved ALK’s ODACTRA® tablet for use in young children with house dust mite (HDM) allergy. ODACTRA® is now indicated to treat HDM-induced allergic rhinitis, with or without conjunctivitis, in children aged five through 11, in addition to patients aged 12 through 65. ODACTRA® is an allergy immunotherapy (AIT) tablet which dissolves under the tongue and helps patients reduce their allergy symptoms and their reliance on symptomatic medication. The FDA approval is an important step in ALK’s efforts to make all its respiratory tablets available for all age groups – children, adolescents, and adults - in all relevant markets. ALK’s Executive Vice President of R&D, Henriette Mersebach (MD), says: “I’m very pleased with the FDA approval of ODACTRA® in young children, as this will enable us to provide an important and potentially life-changing treatment option for children who experience troublesome symptoms and impaired quality of life related to their allergic disease. Building upon our longstanding commitment to developing evidence-based innovative medicines, we now look forward to making ODACTRA® available for children through our US prescriber networks and through commercial and government markets.” The data that formed the basis for the approval includes results from the largest-ever paediatric AIT Phase 3 clinical trial, MT-12, which involved 1,460 children in North America and Europe. The trial demonstrated efficacy and safety of the treatment in children, and the results were recently published in the reputable scientific journal, The Lancet Regional Health – Europe. Globally, it is estimated that more than ten million children, aged five to 11, have uncontrolled respiratory allergies and the number is growing. House dust mites are a common cause of allergy and closely linked to asthma. ALK’s house dust mite allergy tablet is marketed as ODACTRA® in USA, as ACARIZAX® in Europe and several international markets, as MITICURE™ in Japan, and as Sensimune™ in India. Until now, the tablet has been approved for use in young children in Europe and in Japan. A corresponding regulatory review is currently ongoing in Canada. Furthermore, a separate regulatory review of ALK’s tree tablet ITULAZAX® also for use in children is currently ongoing in Europe and Canada. These reviews are expected to complete in 2025, after which all ALK’s tablets will be approved for children, adolescents, and adults in relevant markets. The approval is not expected to affect ALK’s financial outlook for 2025. ALK-Abelló A/S For further information please contact: Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525 Media: Maiken Riise Andersen, tel. +45 5054 1434 About ALKALK is a global specialty pharmaceutical company focused on allergy and allergic asthma. It markets allergy immunotherapy (‘AIT’) treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,800 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net. Attachment Company release_04_25UK_270225_ODACTRA_approval_children

ImmunotherapyDrug ApprovalPhase 3Clinical Result

30 Jan 2025

·www.globenewswire.com

ALK’s house dust mite tablet (ACARIZAX®) now recommended by NICE for use in the UK health system

ALK (ALKB:DC / OMX: ALK B / AKBLF) today announced that the National Institute for Health and Care Excellence (NICE) has recommended the use of ACARIZAX® for the treatment of persistent, moderate to severe house dust mite allergic rhinitis in adults and adolescents. The recommendation paves the way for patients to gain access to ACARIZAX® through the National Health Service (NHS) systems in England, Wales, and Northern Ireland, now making it eligible for general reimbursement. ACARIZAX® is the first sublingual allergy immunotherapy (AIT) product to be assessed and recommended by NICE, and the treatment will be the first of its kind to become widely available through the National Health Service (NHS) systems. The UK is currently one of the few European markets, where ALK’s allergy tablets are authorised without adequate public reimbursement. Additionally, there is a significant underutilisation of AIT in the UK compared to other European countries. ALK’s Executive Vice President of Commercial Operations, Søren Niegel, says: “Today’s news marks a milestone for ALK. NICE’s methodologies and guidelines are widely regarded as the gold standard, and we are proud to become the first and only company to make sublingual allergy immunotherapy tablets widely accessible in the United Kingdom for the benefit of the many patients whose lives are profoundly impacted by allergy.” Allergic rhinitis disease is a prevalent condition in the UK, affecting 26% of adults. Among these, house dust mite is the most common airborne allergy, affecting approximately half of those living with allergic rhinitis disease – upwards of 5 million people in the UK. Despite a range of symptomatic treatment options, approximately one million people still live with debilitating and uncontrolled symptoms. NICE conducts reviews to assess the clinical benefits and cost-effectiveness of healthcare interventions, treatments, and technologies. The institute published a Final Draft Guidance on 30 January 2025, appraising the clinical benefits and cost-effectiveness of ACARIZAX® in the treatment of uncontrolled house dust mite allergy. NICE is expected to publish a Final Guidance in March, after which the NHS systems in England, Wales and Northern Ireland are required to implement ACARIZAX® in the treatment practices. ALK also plans to soon submit a similar application for a NICE review of its sublingual tree tablet, ITULAZAX®. Submissions will also be made to extend the approvals for ACARIZAX® and ITULAZAX® to include children. ALK’s current business in the UK mainly focuses on anaphylaxis (treatment of severe allergic reactions) with the adrenaline pen Jext® on the market and the nasal spray EURneffy® due for launch later this year, pending regulatory approval. AIT tablet sales are currently modest, but ALK expects the combination of its anaphylaxis treatments and the tablets to create long-term synergies in parallel with an expanded infrastructure and as more patients become aware of these treatment options. The NICE approval is not expected to affect ALK’s revenue growth in 2025. ALK-Abelló A/S For further information please contact: Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525 Media: Maiken Riise Andersen, tel. +45 5054 1434 About ALKALK is a global specialty pharmaceutical company focused on allergy and allergic asthma. It markets allergy immunotherapy treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,800 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net. Attachment InvestorNews_30Jan25_ACARIZAX recommended by NICE

ImmunotherapyDrug Approval

100 Deals associated with Birch pollen allergy vaccine(ALK-Abello A/S)

R&D Status

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Indication	Country/Location	Organization	Date
Rhinitis, Allergic, Seasonal	Canada	ALK-Abello A/S	15 Apr 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Rhinitis, Allergic	Phase 2	European Union	ALK-Abello A/S	07 Jun 2019
Ragweed Sensitivity	Phase 2	Italy	ALK-Abello A/S	01 Jun 2011
Asthma	Phase 2	Denmark	ALK-Abello A/S	01 Oct 2007
Rhinoconjunctivitis	Phase 2	Denmark	ALK-Abello A/S	01 Oct 2007
House dust mite allergy	Phase 2	Spain	ALK-Abello A/S	01 Jul 2006
Anaphylaxis	Phase 2	Germany	ALK-Abello A/S	01 Jun 2005

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


GlobeNewswire Manual	Phase 3	Allergic rhinoconjunctivitis	952	ITULAZAX	(ugxvtepfwb) = dfvrvkqpyv dtoxhjlysl (ikkzxkxyfj ) Met	Positive	11 Oct 2023
				placebo	-
NCT00633919 (CTgov)	Phase 2/3	Anaphylaxis \| House dust mite allergy	124	Budesonide nasal spray+SLITone(TM) Dermatophagoides mix+Prednisone tablet+Desloratadine tablet+Salbutamol inhaler+Budesonide/formoterol inhaler (Active)	yjxevcxyqx(glixfspmsl) = apacldmkdu qwtrqxteul (ivrwatqoog, xmzgogugqg - jevgsbjmwa) View more	-	21 Feb 2011
				Placebo+Budesonide nasal spray+Prednisone tablet+Desloratadine tablet+Salbutamol inhaler+Budesonide/formoterol inhaler (Placebo)	yjxevcxyqx(glixfspmsl) = mzypjdsfbn qwtrqxteul (ivrwatqoog, mallowpgze - bhuvnhvfqh) View more

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Birch pollen allergy vaccine(ALK-Abello A/S)

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