Delving into the Latest Updates on House dust mite allergy extract(Stallergenes SA) with Synapse

Overview

Basic Info

Drug Type

Allergen extract

Synonyms

Oralair Mites, S-524101, STAGR 320

+ [6]

Target-

Mechanism

Immunomodulators

Therapeutic Areas

Immune System DiseasesInfectious DiseasesOtorhinolaryngologic Diseases+ [2]

Active Indication

Allergic asthmaRhinitis, Allergic, PerennialAIDS-Related Complex+ [2]

Inactive Indication

allergic rhinitis due to dust miteHouse dust mite allergyPrimary Immunodeficiency Diseases+ [2]

Originator Organization

Shionogi Pharma Co., Ltd.

Active Organization

Stallergenes Greer Ltd.

Shionogi & Co., Ltd.Boryung Biopharma Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

JP (26 Mar 2015),

Rhinitis, Allergic, Perennial

RegulationOrphan Drug (KR)

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Allergic rhinoconjunctivitis due to birch pollen is a seasonal problem which manifests as a combination of nasal symptoms (such as congestion, runny nose, sneezing, itching of the nose) and ocular symptoms (such as red, itchy and watery eyes). For several birch-allergic patients, allergic rhinoconjunctivitis occurs with an oral allergy syndrome.
The purpose of this study is to demonstrate the safety and efficacy of the study drug (STALORAL Birch 300 IR) in children and adolescents with birch pollen-induced allergic rhinoconjunctivitis, with or without asthma, when treated before and during the pollen season.
Approximately 699 children will participate in this study. The study will be conducted worldwide in approximately 80 medical sites in about 12 countries. The total duration of the study will be approximately 20 months.

Start Date14 Nov 2023

Sponsor / Collaborator

Stallergenes Greer Ltd.

JPRN-jRCT2080222929

/ CompletedPhase 3

A Phase 3 Study of S-524101 in the Pediatric Patients with Perennial Allergic Rhinitis

Start Date29 Oct 2015

Sponsor / Collaborator

Shionogi & Co., Ltd.

JPRN-JapicCTI-152981

/ CompletedPhase 3

A Phase 3 Study of S-524101 in the Pediatric Patients with Perennial Allergic Rhinitis

Start Date29 Oct 2015

Sponsor / Collaborator

Shionogi & Co., Ltd.

100 Clinical Results associated with House dust mite allergy extract(Stallergenes SA)

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100 Translational Medicine associated with House dust mite allergy extract(Stallergenes SA)

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100 Patents (Medical) associated with House dust mite allergy extract(Stallergenes SA)

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2

Literatures (Medical) associated with House dust mite allergy extract(Stallergenes SA)

01 Nov 2016·Expert review of clinical immunologyQ3 · MEDICINE

300 IR HDM tablet: a sublingual immunotherapy tablet for the treatment of house dust mite-associated allergic rhinitis

Q3 · MEDICINE

Review

Author: Yang, William H ; Devillier, Philippe ; Demoly, Pascal ; Okamoto, Yoshitaka ; Bergmann, Karl-Christian

INTRODUCTION:

The once-daily 300 index of reactivity (IR) house dust mite (HDM) tablet (Actair®; Stallergenes Greer, Antony, France/Shionogi & Co. Ltd., Osaka, Japan) is the first sublingual immunotherapy (SLIT) tablet to be approved for the treatment of HDM-induced allergic rhinitis. Areas covered: This drug profile reviews the current body of evidence on the efficacy, safety and tolerability of the 300 IR HDM tablet, its pharmacodynamics, and its role in clinical practice. Expert commentary: Data from its clinical development program demonstrate favorable efficacy and safety in adults and adolescents with HDM-induced allergic rhinitis, irrespective of mono- or polysensitization status, or the presence of comorbid mild asthma. The 300 IR HDM tablet is effective from as early as 2 months after treatment initiation, providing allergic symptom control and a reduction in the need for symptomatic medication, while improving health-related quality of life. Clinical efficacy is maintained for 1 year after treatment is stopped.

01 Aug 2016·The Journal of allergy and clinical immunologyQ1 · MEDICINE

Efficacy and safety of sublingual tablets of house dust mite allergen extracts: Results of a dose-ranging study in an environmental exposure chamber

Q1 · MEDICINE

Article

Author: Viatte, Agnès ; Abiteboul, Kathy ; Zeldin, Robert K ; Yang, William H ; Devillier, Philippe ; Montagut, Armelle ; Roux, Michel

BACKGROUND:

In a natural field study, sublingual tablets of house dust mite (HDM) allergen extracts (STG320) were efficacious in treating HDM-associated allergic rhinitis.

OBJECTIVES:

We sought to assess the efficacy and safety of 3 doses of STG320 in an environmental exposure chamber.

METHODS:

In this randomized, double-blind study, adults with HDM-associated allergic rhinitis were given a daily sublingual tablet containing placebo or STG320 at a dose of 500IR, 300IR, or 100IR (IR, index of reactivity) for 6 months. Participants recorded their rhinitis symptoms during 4-hour HDM EEC challenges at randomization and months 1, 2, 4, and 6. The primary efficacy end point was the change from baseline to end of treatment in the area under the curve of the rhinitis total symptom score (ChBLAUCRTSS 0-4h). Differences from the placebo group were analyzed by analysis of covariance. Adverse events (AEs) and routine safety parameters were recorded.

RESULTS:

A total of 355 subjects were randomized to 1 of 4 groups: 500IR (n = 93), 300IR (n = 86), 100IR (n = 89), or placebo (n = 87). The least squares mean differences from placebo in ChBLAUCRTSS 0-4h for the 500IR, 300IR, and 100IR groups indicated a dose-dependent effect, with reductions in symptom scores of 33%, 29%, and 20%, respectively. The most frequent AEs were throat irritation and oral pruritus. There were no reports of anaphylaxis or reports consistent with severe laryngopharyngeal disorders and no use of epinephrine. AEs leading to premature discontinuations were more common in the 500IR group.

CONCLUSIONS:

A dose-dependent effect of sublingual HDM immunotherapy was demonstrated in this environmental exposure chamber study, supporting further development of this treatment.

100 Deals associated with House dust mite allergy extract(Stallergenes SA)

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Allergic asthma	AU	Stallergenes Greer Ltd.	15 Apr 2016
Rhinitis, Allergic, Perennial	JP	Shionogi & Co., Ltd.	26 Mar 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
AIDS-Related Complex	Phase 3	AT	Stallergenes Greer Ltd.	14 Nov 2023
AIDS-Related Complex	Phase 3	BG	Stallergenes Greer Ltd.	14 Nov 2023
AIDS-Related Complex	Phase 3	FI	Stallergenes Greer Ltd.	14 Nov 2023
AIDS-Related Complex	Phase 3	FR	Stallergenes Greer Ltd.	14 Nov 2023
AIDS-Related Complex	Phase 3	DE	Stallergenes Greer Ltd.	14 Nov 2023
AIDS-Related Complex	Phase 3	HU	Stallergenes Greer Ltd.	14 Nov 2023
AIDS-Related Complex	Phase 3	LV	Stallergenes Greer Ltd.	14 Nov 2023
AIDS-Related Complex	Phase 3	LT	Stallergenes Greer Ltd.	14 Nov 2023
AIDS-Related Complex	Phase 3	PL	Stallergenes Greer Ltd.	14 Nov 2023
AIDS-Related Complex	Phase 3	RO	Stallergenes Greer Ltd.	14 Nov 2023

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02443805 (CTgov)	Phase 3	Rhinitis, Allergic, Perennial \| House dust mite allergy	1,607	300 IR (300 IR)	mqcuscuxyu(hxnhaqrrua) = kdewpveajb bckuwuxucz (otfygideis, sokovflfhh - gzjhuvudqu) View more	-	25 Sep 2019
				Placebo (Placebo)	mqcuscuxyu(hxnhaqrrua) = lodpkjqdrv bckuwuxucz (otfygideis, nerdpclpnz - ggyjbkheid) View more
NCT00803244 (CTgov)	Phase 3	Rhinoconjunctivitis \| Primary Immunodeficiency Diseases	381	300 IR (300 IR)	dyzrwrxmac(nsbnctdrol) = hcqpdiklqf avcttjzvat (zxiqailizy, vrbqlcotbn - hoxqkyzmny) View more	-	25 May 2016
				Placebo (Placebo)	dyzrwrxmac(nsbnctdrol) = nlmatpnsnt avcttjzvat (zxiqailizy, egwpvpheop - jnpcqsnkyt) View more
NCT00955825 (CTgov)	Phase 3	Rhinoconjunctivitis \| Rhinitis, Allergic, Seasonal	473	300 IR (300 IR)	rsvyzcpofa(owcddjzdlg) = yicvqxlwkr hawswopoza (lvbtidjciv, igetxjpxem - upnrfuwphx) View more	-	19 May 2016
				Placebo (Placebo)	rsvyzcpofa(owcddjzdlg) = olilijrlwz hawswopoza (lvbtidjciv, qavzqypyqt - tzohrahmnn) View more
NCT00674700 (CTgov)	Phase 2/3	Rhinitis, Allergic \| House dust mite allergy	509	300 IR house dust mites allergen extract tablet (300 IR)	otjansvjua(uaagxkfmdy) = bwjxtktnwv ndmterkutn (fnmgwesthk, zxizotthhg - plyxegboqk) View more	-	19 May 2016
				500 IR house dust mites allergen extract tablet (500 IR)	otjansvjua(uaagxkfmdy) = homkbphutk ndmterkutn (fnmgwesthk, derkfpbpya - dqincnvcho) View more
AAAAI2016	Phase 3	Rhinitis, Allergic positive skin prick test \| nasal provocation test \| HDM-specific IgE	-	STG320 at doses from 100IR to 1,500IR	hoxwmnlots(ibpbestxut) = scmszdjlnj iubkzkohhd (uedutciipd )	-	01 Feb 2016