The primary aim of this trial is to evaluate the efficacy of the ALK house dust mite tablet given once daily compared to a placebo tablet in the treatment of house dut mite allergic rhinits.
Additionally the secondary objective of the trial is to evaluate the safety and tolarability of the ALK house dust mite tablet.
Immunotherapy has been shown to provide therapeutic benefits to subjects with house dust mite induced allergy. This trial is planned to investigate if clinically relevant improvements in rhinitis symptoms and with less use of symptomatic medication can be obtained in subjects with a history of poor didease control despite of use of symptomatic medications.

Start Date01 Oct 2011

Sponsor / Collaborator

ALK-Abello A/S

100 Clinical Results associated with House dust mite allergy vaccine(ALK-Abello A/S)

100 Translational Medicine associated with House dust mite allergy vaccine(ALK-Abello A/S)

100 Patents (Medical) associated with House dust mite allergy vaccine(ALK-Abello A/S)

Literatures (Medical) associated with House dust mite allergy vaccine(ALK-Abello A/S)

01 Jan 2023·Journal of thoracic disease

Allergen-specific immunotherapy with Alutard SQ improves allergic inflammation in house-dust mites-induced allergic asthma rats through inactivation of the HMGB1/TLR4/NF-κB pathway

Article

Author: Zheng, Peiyan ; Li, Jing ; Zhai, Yingying ; Sun, Baoqing ; Wang, Bin

Background:

Allergen-specific immunotherapy (AIT) is the only available safe, effective, and long-term treatment for allergic airway diseases, including allergic asthma. However, the potential molecular mechanism of AIT in ameliorating airway inflammation remains unknown.

Methods:

Rats were sensitized and challenged with house dust mite (HDM) and administered with Alutard SQ or/and high mobility group box 1 (HMGB1) inhibitor, ammonium glycyrrhizinate (AMGZ) or HMGB1 lentivirus. The total and differential cell counts in rat bronchoalveolar lavage fluid (BALF) were detected. Hematoxylin and eosin staining (H&E) was performed to examine the pathological lesions in lung tissues. Enzyme-linked immunosorbent assay (ELISA) was performed to assess the expression of inflammatory factors in lungs, BALF, and serum. Quantitative real-time PCR (qRT-PCR) was used to measure the levels of inflammatory factors in the lungs. Western blot assay was used to evaluate the expression of HMGB1, Τoll-like receptor 4 (TLR4), and nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB) in the lungs.

Results:

Consequently, AIT with Alutard SQ attenuated airway inflammation, the total and differential cells in BALF, and expression of Th (T helper)2 related cytokines and transforming growth factor beta 1 (TGF-β1). The regimen also upregulated Th-1-related cytokine expression by inhibiting the HMGB1/TLR4/NF-κB pathway in HDM-induced asthmatic rats. Furthermore, AMGZ, a HMGB1 antagonist, amplified the functions of AIT with Alutard SQ in the asthma rat model. Nevertheless, overexpression of HMGB1 reversed the functions of AIT with Alutard SQ in the asthma rat model.

Conclusions:

In summary, this work demonstrates the role of AIT with Alutard SQ, which inhibits the HMGB1/TLR4/NF-κB signaling pathway in allergic asthma management.

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 ; Pollock, Richard F. ; Grand, Tobias Sydendal ; Rønborg, Steen M.

Abstract:

Background and aims:

Allergic 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.

Methods:

A 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.

Results:

The 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®.

Conclusions:

Given 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.

16 Feb 2021·Journal of investigational allergology & clinical immunologyQ3 · MEDICINE

Shortened Up-Dosing With 7 Injections of Subcutaneous Allergy Immunotherapy (Alutard SQ) Is Safe and Well Tolerated

Q3 · MEDICINE

Article

Author: Møller Kruse, T ; Fernández-Rivas, M ; Horn, A ; Wolf, H ; Wüstenberg, E ; Koutromanou, K ; Ghaussy, N

A review.Perform a partly randomized, parallel-group, controlled (open-label), multicenter trial to compare the safety and tolerability profile of a 7-injection up-dosing schedule with the registered and widely used AIT product Alutard SQ (ALK, based on either 6 grasses and rye, birch, or HDM allergens) with that of the established 11-injection up-dosing schedule for grass pollen allergens.Patients treated with grass allergen extracts were randomized 1:1 to up-dosing with 11 weekly injections (grass-11) or 7 weekly injections (grass-7).In total, 302 (89%) patients experienced 2755 adverse events (AEs), and 269 (79%) experienced 2162 TRAEs.Four systemic allergic reactions were identified in the grass-11 group (all serious) and 3 in the grass-7 group (1 serious and 2 nonserious), subheading Systemic allergic reaction.Our results suggest that the 7-injection up-dosing schedules for grass, tree, and HDM have an acceptable safety and tolerability profile, which is generally comparable to the 11-injection up-dosing schedule for grass in adolescents and adults (12-65 years) with moderate to severe ARC induced by the resp. allergen.SCIT with Alutard SQ based on the 7-injection up-dosing schedules may improve the convenience of treatment and, thus, facilitate patients' access to the benefits of AIT.

News (Medical) associated with House dust mite allergy vaccine(ALK-Abello A/S)

21 Jun 2024

·www.globenewswire.com

ALK provides update on regulatory process for the house dust mite allergy tablet in China

ALK (ALKB:DC / OMX: ALK B / AKBLF) today announced that it has decided to withdraw the Biologic License Application (‘BLA’) for its house dust mite (‘HDM’) sublingual allergy immunotherapy tablet in China. ALK will continue to work with the authorities to obtain regulatory approval of the HDM tablet in China, which may involve establishing additional clinical data in Chinese patients. The delay in the regulatory approval process does not impact ALK’s financial guidance for 2024, or its ability to reach a 25% EBIT-margin in 2025. Moreover, it does not impact ALK’s ability to meet its previously communicated long-term financial growth ambitions. The BLA for the treatment of persistent moderate-to-severe HDM allergic rhinitis in patients aged 12–65 was accepted for review by the Chinese authorities in February 2023. In March 2022, prior to the submission, the authorities issued a clinical trial waiver, allowing ALK to file for approval based on clinical data obtained from patients outside of China, without the need to complete the clinical trial with Chinese subjects, which had been paused in 2020 due to COVID. Commenting on the decision to withdraw the application, ALK’s Executive Vice President of Research & Development, Henriette Mersebach, says: “We remain committed to bringing innovative treatments to the millions of Chinese people with allergy and their doctors asking for better allergy care. We will work with the authorities in order to resubmit an updated registration application as soon as possible. The continued roll-out of the tablet in certain parts of China’s Medical Pilot Zones is not impacted and continues according to plan. This allows selected prescribers and patients access to care and to gain experience with the treatment.” ALK’s commercial plans and activities in China will be adapted to a new launch timeline (previously planned for 2025), which will be determined following further dialogue with the authorities. ALK’s current business in China is focused on the injectable SCIT product ALUTARD SQ® which has seen sales growing by 30% p.a. on average in recent years (CAGR 2020-23). ALK’s HDM tablet is approved in 43 countries across Europe, North America, Middle-East and the Asia Pacific region for the treatment of persistent moderate-to-severe HDM induced allergic rhinitis and in some countries also for the treatment of HDM induced allergic asthma. 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 2,900 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net. Attachment FM_13_24UK_21062024_final

Immunotherapy

100 Deals associated with House dust mite allergy vaccine(ALK-Abello A/S)

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Asthma	China	ALK-Abello A/S	05 Mar 2004
Rhinitis, Allergic	China	ALK-Abello A/S	05 Mar 2004

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
House dust mite allergy	Phase 3	France	ALK-Abello A/S	01 Oct 2011
Anaphylaxis	Phase 3	Germany	ALK-Abello A/S	01 Apr 2008

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