Staloral (allergy immunotherapy sublingual) / Stallergenes - LARVOL DELTA

Prospective, pilot, phase 1 study of iPUMP© in patients starting sublingual allergen immunotherapy (Staloral©) (EAACI 2024) - "It is easy to use and the functions in the connected device and app. can be consulted by patients to monitor their own compliance."

Clinical • Late-breaking abstract • P1 data • Allergic Rhinitis • Allergy • Immunology • Inflammation

YOBI: Safety and Efficacy of STALORAL® Birch 300 IR in a Paediatric Population With Birch Pollen-induced ARC w/o Asthma (clinicaltrials.gov) - P3 | N=699 | Active, not recruiting | Sponsor: Stallergenes Greer | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Jul 2024 ➔ Nov 2025 | Trial primary completion date: May 2024 ➔ Jul 2025

Enrollment closed • Trial completion date • Trial primary completion date • Allergy • Asthma • Conjunctivitis • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • Pediatrics • Pulmonary Disease • Respiratory Diseases

YOBI: Safety and Efficacy of STALORAL® Birch 300 IR in a Paediatric Population With Birch Pollen-induced ARC w/o Asthma (clinicaltrials.gov) - P3 | N=699 | Not yet recruiting | Sponsor: Stallergenes Greer

New P3 trial • Allergy • Asthma • Conjunctivitis • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • Pediatrics • Pulmonary Disease • Respiratory Diseases

A Multi-national Phase IIIb Trial to Determine the Safety and Efficacy of STALORAL® Birch 300 IR in Children and Adolescents 5 to 17 Years old with Allergic Rhinoconjunctivitis induced by Birch Pollen with or without Asthma.STALORAL® Birch 300 IR will be compared to placebo and neither the patients not the doctors will know the treatment taken by the patients. (clinicaltrialsregister.eu) - P3 | N=1398 | Sponsor: STALLERGENES

New P3 trial • Asthma • Conjunctivitis • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • Pulmonary Disease • Respiratory Diseases

Research Presentations at the 2021 Annual AAAAI Meeting Highlight Limitations of Current Food Allergy Treatments and Further Validates Intrommune Therapeutics’ Approach (GlobeNewswire) - "The clinical and scientific team of Intrommune Therapeutics...presented findings from his group’s investigational study of peanut allergic toddlers (1-4 yrs) with Sublingual Immunotherapy (SLIT)...results suggest that targeting the oral mucosa with SLIT is at least on par with previous studies of daily ingestion of powder peanut protein...A poster presented at the meeting...demonstrated the adoption difficulties of Palforzia (Nestlé Health Science), the only currently FDA-approved treatment for peanut allergy...The presentation collected information on 131 peanut allergy patients who were offered the treatment in their clinic."

Review • Food Hypersensitivity

A Retrospective Nationwide Non-Interventional Study of an Aqueous Sublingual Immunotherapy Formulation Administered with a 200-µL Dosing Pump. (PubMed, Drugs Real World Outcomes) - "Administration of 300 index of reactivity SLIT with a 200-µL dosing pump is safe, well tolerated and associated with good levels of patient satisfaction."

Journal • Observational data • Retrospective data • Allergic Rhinitis • Asthma • Gastrointestinal Disorder • Immunology • Pediatrics • Respiratory Diseases

Comparative analysis of sublingual immunotherapy medicines for adherence and clinical outcomes. (PubMed, Eur Arch Otorhinolaryngol) - "Although 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."

Clinical • Clinical data • Journal • Pruritus

Allergy immunotherapies for allergic rhinitis: systematic review and assessment of evolving quality. (PubMed, Eur Ann Allergy Clin Immunol) - "17 of 44 unique RCTs (38.6%) (sample size range: 18-1,501 subjects) were subcutaneous grass immunotherapy trials and 27 (61.4%) were sublingual grass immunotherapy trials (Allergovit, 5 trials; Alutard, 8; Grazax, 13; Oralair, 6; Staloral, 8; Pollinex, 2; Phostal and Purethal, 1 each). Conclusions. When as-sessing grass AIT, it is important to focus not only on endpoints but also on the quality of evidence."

Journal • Review • Allergic Rhinitis • Allergy • Asthma • Immunology • Respiratory Diseases

[VIRTUAL] Food allergies in children with birch pollen allergy and various profiles of sensitization to pollen components (EAACI 2020) - "125 children received 2 courses of SLIT by birch allergen extract (Staloral)... We found an early onset of symptoms of plant food allergy in children with hay fever. The efficiency of SLIT was higher in patients with monosensitization to Bet v1 in relation to both clinical symptoms of hay fever and PFAS."

Clinical • Allergic Rhinitis • Allergy • Atopic Dermatitis • Dermatitis • Food Hypersensitivity • Immunology

Relevant Patient Benefit of Sublingual Immunotherapy with Birch Pollen Allergen Extract in Allergic Rhinitis: An Open, Prospective, Non-Interventional Study. (PubMed, Adv Ther) - "After 1 year of birch pollen SLIT treatment, patients reported considerable benefit, mainly due to a reduction of physical symptoms and treatment burden."

Clinical • Journal • Observational data • Allergic Rhinitis • Allergy • Asthma • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • Respiratory Diseases

Comparison of Sublingual Immunotherapy in Patients With Allergic Rhinitis Sensitive to House Dust Mites in Korea. (PubMed, Ear Nose Throat J) - "In conclusion, the improvements in symptom score and medication scores were not significant different between 2 SLIT medications at 1 year. LAIS was more compliant, less side effects and Staloral has shown increased satisfaction rate and IgG4 level."

Clinical • Journal

Comparative analysis of sublingual immunotherapy medicines for adherence and clinical outcomes (EAACI 2019) - "Only 1 patient complained adverse reaction such as swelling of mouth floor in Staloral® group.Conclusion Although all three SLIT medicines are effective in improving AR symptoms, the dropout rate was the highest in the Staloral® group. Therefore, we should consider the medication adherence when prescribing SLIT medicines, especially Staloral® for successful treatment outcomes and reducing the possibility of relapse."

Clinical • Clinical data

Efficacy of sublingual immunotherapy in children with birch pollen allergy and different IgE profiles to recombinant component-resolved allergens (EAACI 2019) - "Daily therapy in the maximum permissible dosage was a prognostic factor of treatment efficacy (p <0.01). SLIT by Microgen was only effective against the symptoms of ARC (p=0.0002).Conclusion As the result of the study it was identified that efficacy of SLIT was higher in children with monosensitization to Bet v1 and depends on the drug taken, the dose and frequency of administration."

Clinical

Parallel combination of AITs in a teen-age boy (EAACI 2019) - "This combination improved the patient´s quality of life and enabled the step-down in his therapy. We continue the follow up of this patient."