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 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.

01 Jan 2020·European Archives of Oto-Rhino-LaryngologyQ3 · MEDICINE

Comparative analysis of sublingual immunotherapy medicines for adherence and clinical outcomes

Q3 · MEDICINE

Article

Author: Lee, Yu-Mi ; Cho, Kyu-Sup ; Kim, Ji-A ; Yi, Keun-Ik ; Kim, Sung-Dong ; Mun, Sue-Jean

OBJECTIVESublingual immunotherapy (SLIT) has been considered as an effective and safe alternative to the subcutaneous route. However, different modalities and administration methods may lead to significant changes in their adherence and clinical outcomes. The purpose of this study was to compare the adherence, efficacy, and side effects of SLIT medicines: SLITone^®, Lais^®, and Staloral^®.SUBJECTS AND METHODSEighty-two patients suffering from AR symptoms and sensitized only to house dust mite allergens were included. The patients were treated with SLITone^®, Lais^®, or Staloral^®. Treatment outcomes related to efficacy, dropout rate, and adverse events were evaluated. The visual analogue scale (VAS) including sneezing, rhinorrhea, nasal obstruction, and itching was scored from 0 (normal) to 10 (severe), before and after SLIT. Dropout rate was defined as the number of patients who discontinue SLIT of oneself compared to the number of patients who receive SLIT.RESULTSAll of the nasal symptoms and total symptom scores were significantly decreased in SLITone^®, Lais^®, and Staloral^®. Furthermore, there were significant difference in the improvement of rhinorrhea and TNSS between SLITone^® and Staloral^® group (p = 0.011 and p = 0.001, respectively). Four patients out of 26 in SLITone^® group, 4 patients out of 30 in Lais^® group, and 11 patients out of 26 in Staloral^® group have stopped SLIT of themselves. The dropout rate was significantly higher in the Staloral^® group than other two groups (p = 0.024). Only one patient complained adverse reaction such as swelling of mouth floor in the Staloral^® group.CONCLUSIONAlthough all three SLIT medicines are effective in improving AR symptoms, the adherence to SLIT assessed in accordance with dropout rate was the lowest in the Staloral^®.

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

30 May 2024

·www.globenewswire.com

ALK’s European registration application for ITULAZAX® for paediatric indication accepted for review

ALK (ALKB:DC / OMX: ALK B / AKBLF) today announced that the European regulatory filing for ITULAZAX® (tree sublingual allergy immunotherapy (SLIT) tablet) in young children has been accepted for review by the relevant health authorities. The European regulatory review process is anticipated to take up to nine months so that, subject to approval, the first market introductions in Europe could take place from the first half of 2025. The data used in the European filing include results from a successfully completed Phase 3 clinical trial involving 952 children in Canada and Europe. The trial was a Phase 3, randomised, placebo-controlled trial to study the efficacy and safety of ITULAZAX® in children aged 5 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 achieved its primary endpoint confirming an overall improvement of 22% compared to placebo. Results were highly statistically significant. ALK’s Executive Vice President of Research and Development, Henriette Mersebach, says: “I’m pleased that our registration application for ITULAZAX® for young children has been accepted for review, and we look forward to the dialogue with the European authorities. The results in children are robust and consistent with previous trial results and this filing represents an important step forward for our ability to transform the medical treatment of children with tree pollen allergy as well as for ALK’s long-term growth ambitions.” Globally, it is estimated that more than 10 million children have uncontrolled respiratory allergies, and the number is growing. Tree pollen is a common cause of these uncontrolled allergies. In Europe, the ITULAZAX® tablet is currently approved for treatment of patients aged 18-65. ALK-Abelló A/S For further information, please contact: Investor Relations: Per Plotnikof, tel. +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_30May2024_ITULAZAX

Clinical ResultPhase 3ImmunotherapyDrug Approval

18 Jan 2024

·www.globenewswire.com

ALK completes first part of phase 1 trial with peanut SLIT-tablet

The trial now progresses into its second part, expected to complete later in 2024. ALK to submit a protocol amendment for Phase 1-2 efficacy trial extension. ALK (ALKB:DC / OMX: ALK B / AKBLF) announced today that it has completed the first part of its phase 1 clinical trial (named ‘ALLIANCE’) for its investigational sublingual immunotherapy (‘SLIT’) tablet for the treatment of peanut allergy. The first part of the trial investigated the safety and tolerability of 14 days treatment with the peanut tablet at different starting doses. For all dose levels, the peanut tablet was shown to be safe and tolerable and with a safety and tolerability profile in accordance with that of the approved SLIT-tablets (ACARIZAX/ODACTRA®, GRAZAX®/GRASTEK®, RAGWIZAX®/RAGWITEK®, ITULAZAX®/ITULATEK®). No serious adverse events and no cases of treatment emergent anaphylaxis were reported. Based on results from part 1, the starting dose for the second part of the study has been selected. This part of the study will evaluate the safety and tolerability of up-dosing to the highest tolerable maintenance dose. The second part will be initiated imminently and is scheduled to complete later in 2024. Furthermore, ALK has decided to amend the ALLIANCE study protocol to include a third part involving approximately 100 additional patients. This part will evaluate safety and efficacy of the peanut SLIT-tablet as assessed by an oral food challenge following a period of maintenance treatment. The implementation of the third part is contingent upon a successful outcome of the second part. The revised protocol is expected soon to be submitted to the relevant authorities. ALK’s Executive Vice President of Research and Development, Henriette Mersebach, says: “We are pleased to report positive progress in our ALLIANCE trial, addressing potentially life-threatening peanut allergy. Encouraged by the initial results for the peanut tablet, we have made a provisional decision to extend the trial into a seamless Phase 1-2 design allowing us to explore the efficacy of the tablet as well. Leveraging our profound R&D expertise, we remain committed to developing valuable new treatment options for people with allergy”. In the USA, peanut allergy affects up to 1.5 million children and adolescents aged 4-17, while in Europe, around 1 million children and adolescents are affected by this potentially life-threatening condition. The disease often presents in early childhood and can last a lifetime. For some of these patients, allergy immunotherapy may become a relevant treatment option with the potential to improve quality of life, both for them and their families. This announcement is not expected to materially change the R&D cost outlook for 2024-25. 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 This information is information that ALK is obliged to make public pursuant to the EU Market Abuse Regulation. About the ALLIANCE trialInitiated in 2022, the ALLIANCE trial was designed to assess the tolerability and safety of an up-dosing regimen with a once-daily peanut SLIT-tablet in adults, adolescents, and children. The trial is a phase I, open-label, dose-escalation, multi-site trial conducted in North America, with approximately 100 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 to assess safety and tolerability of the up-dosing regimen as well as gather early data on its biological action. The third part intends to investigate safety and efficacy of selected doses of the peanut SLIT-tablet compared with placebo. The 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 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 FM_01_2024UK_18012024

ImmunotherapyPhase 1

15 Nov 2023

·www.globenewswire.com

Nine-month interim report (Q3) 2023

ALK delivers 8% revenue growth with operating profit up 128% in Q3 (unaudited) ALK saw growth in all sales regions in Q3, led by sales of tablets and SCIT. As expected, European tablet sales picked up and grew by 14%, mainly driven by new patient initiations. Operating profit (EBIT) increased by 128% in local currencies on sales growth and gross margin improvements. Q3 2023 financial highlights Comparative figures for Q3 2022 are shown in brackets. Revenue growth rates are stated in local currencies, unless otherwise indicated Total revenue increased by 8% in local currencies to DKK 1,110 million (1,062), equalling 9% growth when disregarding the one-year rebate increase in Germany. Currencies lowered reported growth by 3 p.p.Tablet sales increased by 10% to DKK 491 million (458) on 14% growth in Europe and 26% growth in North America while sales in International markets decreased 5% due to phasing of product shipments to Japan.Combined SCIT/SLIT-drops sales increased by 23% to DKK 484 million (407), fuelled by continued growth across Europe and an extraordinarily high level of product shipments to China.Sales of Other products and services decreased by 28% to DKK 135 million (197) as Jext® sales, as anticipated, declined steeply due to intermittent supply shortages from ALK’s contract manufacturer of adrenaline-filled cartridges. The decline in Jext® sales lowered overall revenue growth by 4 p.p. in Q3.Operating profit (EBIT) increased by 128% in local currencies and by 116% in reported currency to DKK 147 million (68) on sales growth, gross margin improvements and a modest decline in capacity costs, as certain sales and marketing activities saw some phasing between Q3 and Q4. Financial performance for the first nine months 2023 in DKKm9M 2023 9M 2022 Growth (local currencies) Growth (reported) Revenue3,4793,2629% 7% EBIT47233255% 42% EBIT margin - % 14%10% Progress on strategic priorities Based on the recent successfully completed Phase 3 trial, ALK has started preparing a registration application for authorities in Europe and Canada with the aim of expanding the indication of the tree tablet (ITULAZAX®) to include patients aged five to 17.Registration applications with the aim of expanding indications for the house dust mite (HDM) tablet (ACARIZAX®) to include children are expected to be submitted to the European and American authorities in the near future.First interim readouts from the Phase 1 trial of the tablet treatment for peanut allergy are still expected end-2023.The regulatory review of the BLA for the HDM tablet in China is ongoing. Unchanged 2023 outlook The full-year revenue and earnings outlook remains unchanged: Revenue is expected to grow by 8-10% organically in local currencies, equivalent to 9-11% growth, disregarding the one-year, temporary mandatory rebate increase in Germany.Global tablet sales and SCIT/SLIT-drops sales are still expected to grow by double digits respectively in the second half of the year. ALK still expects ~10% growth in tablet sales in Europe for the second half year. Full-year tablet growth is still expected within the previously communicated range.The EBIT margin is still expected to increase from 10% in 2022 to 13-15% on sales growth, efficiencies, economies of scale and lower R&D costs. Commenting on the Q3 results, ALK’s new CEO Peter Halling said: “ALK’s Q3 results met our expectations, and we remain on course to deliver on our full-year sales and earnings outlook. We are pleased to see sales growth in every region, particularly the increasing tablet growth in Europe due to the introduction of AIT treatments to more patients. Additionally, we are excited about the positive results from the recent Phase 3 paediatric studies, reinforcing our long-term growth prospects. Being new to the company, I want to thank all employees for their warm welcome and for their dedicated efforts.” Hørsholm, 15 November 2023 ALK-Abelló A/S For further information, contact: Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525Media: Maiken Riise Andersen, tel. +45 5054 1434 Today, ALK is hosting a conference call for analysts and investors at 1.30 p.m. (CET) at which Management will review the financial results and the outlook. The conference call will be audio cast on https://ir.alk.net where the relevant presentation will be available shortly before the call begins. To register for the conference call, please use this link https://dpregister.com/sreg/10183783/fad25cbd21 and follow the registration instructions. You will receive an email from diamondpass@choruscall.com with dial-in details, including a passcode and a pin code. Please make sure to whitelist diamondpass@choruscall.com and/or check your spam filter. We advise you to register on the day before the call at the latest. Attachment FM_15_23UK_15112023

Financial StatementPhase 1Phase 3

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

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Approved

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Indication	Country/Location	Organization	Date
Rhinitis, Allergic, Seasonal	CA	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	Discovery	EU	ALK-Abello A/S	07 Jun 2019
House dust mite allergy	Discovery	ES	ALK-Abello A/S	01 Jul 2006
Anaphylaxis	Discovery	DE	ALK-Abello A/S	01 Jun 2005
Rhinitis, Allergic, Seasonal	Discovery	DE	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	ysufxajqkq(cpqdvwnssm) = dinqaoyohi uwrxnauore (gcnixudaqm ) 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)	ksmkgyeorb(tihhfszeyv) = dnwtcfjebr bjsffspyoy (bajzeqqolh, lkurgyphuq - nkzbvqdwss) View more	-	21 Feb 2011
				Placebo+Budesonide nasal spray+Prednisone tablet+Desloratadine tablet+Salbutamol inhaler+Budesonide/formoterol inhaler (Placebo)	ksmkgyeorb(tihhfszeyv) = eakeoywxzt bjsffspyoy (bajzeqqolh, hpoimehanm - dkkauodsuh) View more

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

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