Delving into the Latest Updates on Grass pollen allergy immunotherapy(Laboratorios LETI SL) with Synapse

Overview

Basic Info

Drug Type

Allergen extract

Synonyms

Depigoid Grass Mix, Depigoid Phleum, Depigoid Phleum pratense

+ [3]

Target-

Mechanism

Immunomodulators

Therapeutic Areas

Immune System DiseasesInfectious DiseasesEye Diseases+ [2]

Active Indication

Conjunctivitis, AllergicRhinitis, Allergic, Seasonal

Inactive Indication

AnaphylaxisAsthmaIntermittent asthma+ [2]

Originator Organization

LETI Pharma SLU

Active Organization

LETI Pharma SLU

Inactive Organization

LETI Pharma GmbH

Drug Highest PhaseApproved

First Approval Date-

Regulation-

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A randomized (open-label design), parallel group, multicentre study to evaluate the safety and tolerability of two different doses of Depigoid 34% GrassesMix, 33% Olea europaea and 33% Salsola kali a 3000 DPP/ml in subjects with allergic rhinitis or rhinoconjunctivitis, with or without controlled asthma.

Start Date23 Oct 2014

Sponsor / Collaborator-

EUCTR2013-004920-12-CZ / Not yet recruitingPhase 2

Non-interventional Study in Allergic Patients Suffering from Grass Pollen Induced Rhinitis/Rhinoconjunctivitis with or without Asthma.Retrospective Assessment of the Efficacy of a Perennial Specific Immunotherapy on the Allergy Symptoms / Disease Activity during the Pollen Season - Depigoid Phleum - PRO 2013

Start Date12 Feb 2014

Sponsor / Collaborator

LETI Pharma GmbH

100 Clinical Results associated with Grass pollen allergy immunotherapy(Laboratorios LETI SL)

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100 Translational Medicine associated with Grass pollen allergy immunotherapy(Laboratorios LETI SL)

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100 Patents (Medical) associated with Grass pollen allergy immunotherapy(Laboratorios LETI SL)

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9

Literatures (Medical) associated with Grass pollen allergy immunotherapy(Laboratorios LETI SL)

01 Jan 2019·International Archives of Allergy and ImmunologyQ3 · MEDICINE

Comparison of Six Different Allergen Extracts for Subcutaneous Specific Immunotherapy in Children: An Open-Labelled, Prospective, Controlled Observational Trial

Q3 · MEDICINE

Article

Author: Millner-Uhlemann, Martina ; Kopp, Matthias Volkmar ; Umpfenbach, Hans Ulrich ; König, Inke R ; Niggemann, Bodo ; Friedrichs, Frank

Background: Numerous products are available for subcutaneous (SCIT) and sublingual allergen-specific immunotherapy, but there are no information about the direct comparability regarding efficacy, safety, and tolerability of the different extracts. Aims: The aim of this open-labelled, prospective, controlled observational trial was to test the feasibility of a comparison of different products for SCIT in children. Methods: Pediatrician practices recruited patients with a confirmed diagnosis of a seasonal allergic rhinoconjunctivitis (AR) with or without asthma and an allergic sensitization against grass pollen allergen. Every patient was offered SCIT with one out of six allergen extracts: ALK SQ Depot, ALK Avanz, Allergovit, Depigoid, Purethal, Pollinex Quattro. Scores for symptoms and medications were calculated and the difference between treatment years and baseline were recorded. Results: In total, 284 were recruited and 255 children (89.8%; mean age 10.4, SD 3.54 years; 65% males) participated in this trial. Overall, 49,649 patient days were recorded in the electronic database (mean 183.2 days/patient). There was no significant difference in the AR and asthma symptom score or the medication score between the six different SCIT preparations. Similarly, no differences were observed in terms of safety and tolerability. Conclusion: The comparison of different SCIT products using an online tool is feasible. Based on our preliminary data, all extracts indicated efficacy; however, larger groups would be necessary to demonstrate superiority or non-inferiority of one specific SCIT product.

01 Jun 2017·Immunity, Inflammation and DiseaseQ4 · MEDICINE

AIT to HDM: A non-interventional study report

Q4 · MEDICINE

ArticleOA

Author: Zimmermann, Jürgen ; Klein, Christian ; Mahler, Vera ; Sager, Angelika

INTRODUCTIONHouse dust mite (HDM) allergens are major causes for the development of allergic diseases. A disease modifying effect and clinical benefit of allergen immunotherapy (AIT) has been demonstrated in a number of clinical trials. Clinical trials, however, are carried out in selected populations under specific conditions based on inclusion and exclusion criteria and may not represent the entire patient population from medical practice. Objective of this study conducted in patients with HDM allergy was to systematically collect information about the benefit of AIT under clinical routine conditions.METHODSIn this prospective, multi-center non-interventional study, 220 patients (117 adults, 103 children) with HDM allergy receiving subcutaneous AIT with Depigoid^® were monitored for 2 years. Organ-specific key symptoms, health-related quality of life (QoL), and the use of concomitant anti-allergic medication were assessed at baseline and after 12 and 24 months. Effectiveness and tolerability of the AIT was assessed by physicians and patients. Occurrence of adverse events (AEs) was continuously monitored.RESULTSTwo hundred and nineteen patients (116 adults, 103 children) were evaluated. A major improvement of the total symptom-score was observed after 24 (12) months in 76% (72%) and 80% (79%) of adults and children, respectively, accompanied by a reduction in concomitant anti-allergic medication and a pronounced improvement in QoL. The effectiveness and tolerability of the AIT was estimated as very good/good by 80-90% of physicians and patients. AEs were observed in 4/117 adults (3.4%) and in 7/103 children (6.8%). Serious AEs were reported in three adults and one child: A grade-II anaphylactic reaction (one adult) controlled by oral antihistamines (no hospitalization) classified as "definitely," three others as not (2) or possibly (1) drug-related.CONCLUSIONSThe data collected from 220 patients confirm the efficacy, tolerability/safety, and acceptance of AIT with Depigoid^® in adults and children with HDM allergy under routine clinical conditions.

01 Aug 2013·Pediatric Allergy and ImmunologyQ1 · MEDICINE

Transient impact of omalizumab in pollen allergic patients undergoing specific immunotherapy

Q1 · MEDICINE

Article

Author: Klein, Christian ; Wahn, Ulrich ; Kopp, Matthias Volkmar ; Hamelmann, Eckard ; Zielen, Stefan ; Bergmann, Karl‐Christian ; Kamin, Wolfgang ; Bendiks, Meike

AbstractBackgroundRecently, we showed that combination of omalizumab with specific immunotherapy (SIT) for treatment of patients with seasonal allergic rhinitis (SAR) and comorbid seasonal allergic asthma (SAA) is safe and reduced the symptom load in a statistically significant and clinically meaningful manner during the first pollen season.ObjectiveThe aim of this study was to investigate long‐lasting effects of an initial combination treatment with SIT+omalizumab, a monoclonal anti‐IgE antibody, in a follow‐up period with SIT treatment only in patients with SAR and comorbid SAA incompletely controlled by conventional pharmacotherapy.MethodsA randomized, double‐blind, placebo‐controlled, multicenter trial was performed to assess the efficacy and safety of omalizumab (Xolair®) vs. placebo in combination with SIT (depigmented allergoid vaccine, Depigoid®) during the first grass pollen season. Omalizumab or placebo therapy was started 2 wk before SIT; the whole treatment lasted 18 wk. After the first pollen season, SIT was given for two subsequent years without omalizumab. Primary end‐point was daily ‘symptom load’, the sum of daily scores for symptom severity and rescue medication use in the second and third year.ResultsA total of 140 patients (age 11–46 yr) were randomized; 130, 128, and 114 patients finished the study after 1, 2, and 3 yr, respectively. The main efficacy variable was the mean daily symptom load as assessed in the patients' diary. No systematic differences between both analysis groups were detected in the findings from symptom load, symptom severity score, or rescue medication score. Further subjective data did not show differences between both groups in the quality‐of‐life data as assessed with the ACQ, AQLQ, and the RQLQ. Investigators' assessment of treatment effectiveness in the first and second year of study extension showed more patients with favorable long‐term treatment outcome (‘excellent’ and ‘good’) in the SIT plus omalizumab group than in the SIT plus placebo group. In line with these findings, FEV1 improved at the end of both years in the group which was treated with the combination therapy in the double‐blind study compared with the Depigoid plus placebo group.ConclusionEighteen weeks' treatment of omalizumab in combination with SIT in patients with SAR and comorbid SAA reduced the symptom load during the treatment period but showed no prolonged effect during treatment with SIT only. A slight increase in lung function (FEV1) in patients formerly treated with the omalizumab/SIT combination therapy should encourage further evaluation of long‐term effects of omalizumab.

100 Deals associated with Grass pollen allergy immunotherapy(Laboratorios LETI SL)

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External Link

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Conjunctivitis, Allergic	-	LETI Pharma SLU	-
Rhinitis, Allergic, Seasonal	-	LETI Pharma SLU	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Anaphylaxis	Phase 3	ES	LETI Pharma SLU	01 Nov 2012
Asthma	Phase 3	ES	LETI Pharma SLU	01 Nov 2012
Rhinitis, Allergic, Seasonal	Phase 3	DE	LETI Pharma GmbH	01 Oct 2012
Intermittent asthma	Phase 3	ES	LETI Pharma SLU	01 Jun 2012
Rhinoconjunctivitis	Phase 3	ES	LETI Pharma SLU	01 Jun 2012
Intermittent asthma	Discovery	ES	LETI Pharma SLU	01 Jun 2012
Mild persistent asthma	Discovery	ES	LETI Pharma SLU	01 Jun 2012
Rhinitis, Allergic	Discovery	ES	LETI Pharma SLU	01 Jun 2012
Rhinoconjunctivitis	Discovery	ES	LETI Pharma SLU	01 Jun 2012

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00396409 (CTgov)	Phase 3	Allergic asthma \| Seasonal allergic conjunctivitis	128	Depigoid+Omalizumab (Depigoid + Omalizumab)	lppoeghdwy(lxknpmoxii) = dmgrewwlfo bbejkjuikl (qfcaycgrwg, tyfmunpqpx - lradwgtiyp) View more	-	03 Jun 2011
				Placebo+Depigoid (Depigoid + Placebo)	lppoeghdwy(lxknpmoxii) = kzbvyghtka bbejkjuikl (qfcaycgrwg, vwxfiumcwg - ddcuhkrnwc) View more