Delving into the Latest Updates on Short ragweed pollen allergen extract(ALK-Abello A/S) with Synapse

Post hoc analyses of randomized placebo-controlled trials have demonstrated efficacy and tolerability of the ragweed sublingual immunotherapy (SLIT)-tablet in Canadian adults with ragweed pollen-induced allergic rhinitis/conjunctivitis (AR/C). This post hoc analysis evaluated the efficacy and tolerability of the ragweed SLIT-tablet in the subpopulation of Canadian children and adolescents with AR/C in a previously described randomized, double-blind, placebo-controlled trial.

Methods:

The trial (NCT02478398) was conducted in North American and European children/adolescents ages 5–17 years with ragweed pollen-induced AR/C with or without asthma (FEV1 ≥ 80% predicted). Participants were randomized to daily ragweed SLIT-tablet (12 Amb a 1-U) or placebo for up to 28 weeks. The primary endpoint was the average total combined score (TCS; sum of rhinoconjunctivitis daily symptom score [DSS] and daily medication score [DMS]) during peak ragweed pollen season (RPS). Key secondary endpoints were TCS during the entire RPS, and DSS and DMS during peak RPS. Post hoc analyses of the primary and key secondary endpoints were conducted in the subpopulation of Canadian participants.

Results:

Of the 1025 randomized participants, 246 (SLIT-tablet, n = 116; placebo, n = 130) were in the Canadian subpopulation. In the total study population, relative TCS (95% CI) improvement with ragweed SLIT-tablet versus placebo was − 38.3% (− 46.0%, − 29.7%; least square [LS] mean difference, − 2.73; P < 0.001) during peak RPS. In the Canadian subpopulation, relative TCS improvements with ragweed SLIT-tablet versus placebo were − 40.8% (− 54.5%, − 20.2%; LS mean difference, − 1.59; P = 0.001) during peak RPS and − 36.6% (− 50.2%, − 16.5%; LS mean difference, − 1.36; P = 0.002) during the entire RPS. DSS and DMS during peak RPS in the Canadian subpopulation improved with SLIT-tablet versus placebo by − 30.6% (− 45.2%, − 7.7%; LS mean difference, − 0.94; P = 0.010) and − 77.2% (− 97.5%, − 44.2%; LS mean difference, − 0.66; P = 0.003), respectively. No events of anaphylaxis, airway compromise, intramuscular epinephrine administration, eosinophilic esophagitis, or severe treatment-related systemic allergic reactions were reported in the overall population or Canadian subpopulation.

Conclusion:

Efficacy and safety of the ragweed SLIT-tablet in Canadian children/adolescents with ragweed pollen-induced AR/C was consistent with the total study population. The ragweed SLIT-tablet resulted in clinically meaningful improvement in symptoms, decreased symptom-relieving medication use, and was well tolerated in Canadian children/adolescents.Trial registration: clinicaltrials.gov, NCT02478398. Registered June 23, 2015, https://clinicaltrials.gov/ct2/show/NCT02478398?term=NCT02478398&draw=2&rank=1

01 Dec 2020·PharmacoEconomics - open

Application of a Mapping Function to Estimate Utilities for Ragweed Allergy Immunotherapy Trials

Article

Author: Briggs, Andrew ; Brandi, Henrik ; Dick, Katherine

BACKGROUND:

Ragweed pollen sensitivity is a common cause of allergic rhinitis (AR) worldwide. AR symptoms include itchy and runny eyes, sneezing, blocked nose, impaired sleep and social and emotional problems, which can have a significant impact on quality of life.

OBJECTIVE:

The objective of this analysis was to estimate utilities for two pooled standardised quality (SQ) ragweed sublingual immunotherapy (SLIT) tablet trials by applying a previously developed mapping algorithm. This study validated the algorithm and extended its application to ragweed seasonal allergy trials. The mapping algorithm relates disease-specific quality-of-life scores to preference-based utilities that may be used to calculate quality-adjusted life-years (QALYs) in cost-effectiveness studies.

METHODS:

A mapping algorithm based on a grass pollen allergy immunotherapy trial, GT-08 (EudraCT no. 2004-000083-27) was applied to pooled data from two ragweed pollen immunotherapy trials, P05233 (EudraCT 2008-003863-38) and P05234 (EudraCT 2008-003864-20) to generate EuroQoL 5-Dimensions, 3-Levels (EQ-5D-3L) utilities from Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) data.

RESULTS:

The mean utility difference between the SQ ragweed SLIT tablet and placebo was 0.025 [95% confidence interval (CI) 0.011-0.038]. The SQ ragweed SLIT tablet showed an incremental quality-adjusted life-days (QALDs) benefit of 1.900 (95% CI 0.835-2.916) over 75 days.

CONCLUSIONS:

Application of a previously developed mapping function allowed for the calculation of QALDs associated with the SQ ragweed SLIT tablet. The results showed a QALD benefit of the SQ ragweed SLIT tablet in P05233 and P05234 trials in the treatment of ragweed pollen-induced AR.

01 Jul 2020·The journal of allergy and clinical immunology. In practiceQ1 · MEDICINE

Efficacy and Safety of Ragweed SLIT-Tablet in Children with Allergic Rhinoconjunctivitis in a Randomized, Placebo-Controlled Trial

Q1 · MEDICINE

Article

Author: Nelson, Harold S ; Kleine-Tebbe, Jörg ; Nolte, Hendrik ; Ellis, Anne K ; Lu, Susan ; Bernstein, David I

BACKGROUND:

Ragweed sublingual immunotherapy (SLIT) tablet reduces symptoms and symptom-relieving medication use in adults with allergic rhinitis with or without conjunctivitis (AR/C) but has not been evaluated in children.

OBJECTIVE:

This international, multicenter, double-blind, placebo-controlled trial evaluated the efficacy and safety of ragweed SLIT-tablet in children with AR/C.

METHODS:

Children (N = 1025; 77.7% polysensitized) aged 5 to 17 years with ragweed pollen-induced AR/C with or without asthma (FEV₁ ≥80% predicted) were randomized 1:1 to daily ragweed SLIT-tablet (12 Amb a 1-Unit) or placebo for up to 28 weeks (NCT02478398). The primary end point was the average total combined score (TCS; sum of rhinoconjunctivitis daily symptom score [DSS] and daily medication score [DMS]) during peak ragweed pollen season (RPS). Key secondary end points were TCS during the entire RPS, and DSS and DMS during the peak RPS.

RESULTS:

Relative TCS (95% CI) improvements with ragweed SLIT-tablet versus placebo were -38.3% (-46.0% to -29.7%; least square [LS] mean difference, -2.73; P < .001) during peak RPS and -32.4% (-40.7% to -23.3%; LS mean difference, -1.86; P < .001) during the entire RPS. DSS and DMS during peak RPS improved with SLIT-tablet versus placebo by -35.4% (-43.2% to -26.1%; LS mean difference, -1.40; P < .001) and -47.7% (-59.8% to -32.5%; LS mean difference, -1.84; P < .001), respectively. Asthma DSS, short-acting β-agonist use, and nocturnal awakenings during peak RPS improved with SLIT-tablet versus placebo by -30.7%, -68.1%, and -75.1%, respectively (all nominal P ≤ .02). No events of anaphylaxis, airway compromise, or severe treatment-related systemic allergic reactions were reported.

CONCLUSIONS:

Ragweed SLIT-tablet significantly improved symptoms and decreased symptom-relieving medication use in children with ragweed pollen-induced AR/C and was well tolerated.

2

News (Medical) associated with Short ragweed pollen allergen extract(ALK-Abello A/S)

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

19 Apr 2021

·www.biospace.com

U.S. FDA Approves ALK's RAGWITEK® (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use as Immunotherapy for Children and Adolescents With Short Ragweed Pollen-Induced Allergic Rhinitis With or Without Conjunctivitis

U.S. FDA Approves ALK's RAGWITEK® (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use as Immunotherapy for Children and Adolescents With Short Ragweed Pollen-Induced Allergic Rhinitis With or Without Conjunctivitis About ALK ALK is a global allergy solutions company, with a wide range of allergy treatments, products and services that meet the unique needs of allergy sufferers, their families and doctors. Headquartered in Hørsholm, Denmark, the company employs around 2,500 people worldwide and is listed on Nasdaq Copenhagen. To learn more about ALK and allergies, visit . For further information, please contact: ALK: Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525 Media: Stuart Loesch, tel. +1 908 842 8363, mobile +1 267 753 5838 View original content to download multimedia: SOURCE ALK, INC.

Immunotherapy

100 Deals associated with Short ragweed pollen allergen extract(ALK-Abello A/S)

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Conjunctivitis, Allergic	RU	ALK-Abello A/S	31 Dec 2019
Conjunctivitis	US	Merck Sharp & Dohme Corp.	17 Apr 2014
Conjunctivitis	US	ALK-Abello A/S	17 Apr 2014
Rhinitis, Allergic	US	ALK-Abello A/S	17 Apr 2014
Rhinitis, Allergic	US	Merck Sharp & Dohme Corp.	17 Apr 2014
Rhinitis, Allergic, Seasonal	FR	-	01 Jan 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Allergic rhinoconjunctivitis	Phase 3	-	Merck Sharp & Dohme Corp.	20 Jul 2015
Asthma	Phase 3	-	Merck Sharp & Dohme Corp.	20 Jul 2015
Anaphylaxis	Phase 3	-	ALK-Abello A/S	01 Nov 2011
Ragweed Sensitivity	Phase 3	-	ALK-Abello A/S	01 Nov 2011
allergic rhinitis with asthma	Phase 3	-	ALK-Abello A/S	01 Sep 2009
Rhinoconjunctivitis	Phase 2	-	ALK-Abello A/S	01 Nov 2009
Hypersensitivity	Phase 1	US	Lundbeckfonden	01 May 2006

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Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02478398 (CTgov)	Phase 3	Rhinitis, Allergic, Seasonal \| Asthma \| Allergic rhinoconjunctivitis	1,025	Mometasone furoate monohydrate+Self-injectable epinephrine+Olopatadine+Albuterol+Loratadine+Short ragweed pollen allergen extract (Short Ragweed Pollen Allergen Extract)	yxripfsgvi(gxvwfatmyf) = paodtdisxs stjlqgrqpd (hjgdvcwmdr, qinbbgbjor - gzsavdccpy) View more	-	09 Jul 2019
				Placebo+Mometasone furoate monohydrate+Self-injectable epinephrine+Olopatadine+Albuterol+Loratadine (Placebo)	yxripfsgvi(gxvwfatmyf) = bmgbopcdlf stjlqgrqpd (hjgdvcwmdr, yldyjhyrif - diwtqqkzxb) View more
NCT02256553 (P08607, CTgov)	Phase 4	Rhinitis, Allergic, Seasonal \| Conjunctivitis	102	MK-7243+MK-3641 (MK-3641+MK-7243)	iibccfdlub(qhcvpzuljb) = vxvdutmpnu xlzvarjsrd (dxadhhszdb, zvrkryxdkw - ppvughwucy) View more	-	18 Jan 2016
				MK-7243 (Period I: MK-7243)	podrfhvocm(gclimpeymt) = dedsitiuuh gmgrmtfyti (yknhvpdvmu, ooekciuant - iadvimzlla) View more
NCT00783198 (P05233, CTgov)	Phase 2/3	Allergic rhinoconjunctivitis \| allergic rhinitis with asthma	565	SCH 39641 6 Amb a 1-U (SCH 39641 6 Amb a 1-U)	frrikobjfp(zezvybgvsr) = nofqjqzoeu gijiubliqo (cyuvwqwggq, sdfwhqkqmx - uuzwmvivsx) View more	-	14 Jul 2014
				SCH 39641 12 Amb a 1-U (SCH 39641 12 Amb a 1-U)	frrikobjfp(zezvybgvsr) = imwkkwzqpa gijiubliqo (cyuvwqwggq, oacvuofyck - dohogriaqi) View more
NCT01469182 (P05751, CTgov)	Phase 3	Ragweed Sensitivity \| Anaphylaxis	914	SCH 39641 (SCH 39641 12 Amb a 1-U)	xuvofxrmsc(flnhhqjaoa) = ktghqzsrjm dfazzqwukq (mkakwjrfno, qzhrudhyql - kiwnlalkrb) View more	-	05 Jun 2014
				Placebo for SCH 39641 (Placebo)	xuvofxrmsc(flnhhqjaoa) = ejxwqutksx dfazzqwukq (mkakwjrfno, ozqjppylbc - qyhqvyhpdi) View more
NCT00978029 (P06081, CTgov)	Phase 2	Rhinoconjunctivitis \| Allergic rhinoconjunctivitis \| Anaphylaxis	203	Placebo (Placebo)	gwuyewfitv(hnpfkuqdyl) = cobicgeezd runpjzgeml (xsvaqqlrba, brjpscptlp - jnjyhaucpb) View more	-	23 May 2014
				SCH 39641 (SCH 39641 6 Amb a 1-U)	gwuyewfitv(hnpfkuqdyl) = fgfqbyroze runpjzgeml (xsvaqqlrba, tpmgrmgvsh - tqvhebpfap) View more
AAAAI2014	Not Applicable	-	-	Placebo	emvvthlqvd(hwjzfpseil) = nayogqfmpn xlpxycjghs (xfqxvaotaq ) View more	-	01 Feb 2014
				6 Amb a 1-U	emvvthlqvd(hwjzfpseil) = olydhbbolo xlpxycjghs (xfqxvaotaq ) View more