Allergic rhinoconjunctivitis

The Phase 3 efficacy and safety trial of ALK’s tree tablet involved 952 children aged 5 to 17 in Canada and Europe.ALK has now successfully completed pivotal clinical development for all five respiratory allergy immunotherapy tablets across all relevant age groups. ALK (ALKB:DC / OMX: ALK B / AKBLF) today announced top-line results from a Phase 3 paediatric clinical trial of its sublingual allergy immunotherapy tablet for the treatment of tree-pollen-induced allergic rhinoconjunctivitis. The tree tablet is marketed as ITULAZAX® in Europe and as ITULATEK® in Canada for patients aged 18 to 65. The trial achieved its primary endpoint and confirmed the effect of the tree tablet with an improvement of 22% in the total combined rhinoconjunctivitis score (TCS) during the birch pollen season compared to placebo. Results were highly statistically significant (p=0.0004), with a lower bound of the 95%-confidence interval of 10.6%. The trial also demonstrated improvement in TCS during the entire tree pollen season (key secondary endpoint). In addition, the trial demonstrated that treatment with the tree tablet was well tolerated and had a favourable safety profile, similar to the safety profile reported in other trials. The trial was well conducted with 96% of patients completing the trial. This trial confirms previous results reported in ALK’s tablet trials and was conducted in accordance with ALK’s strategy to focus on children and to treat allergies at an early stage in life. The trial, which involved 952 children in Canada and Europe, was a Phase 3, randomised, placebo-controlled trial to study the efficacy and safety of ALK’s tree tablet 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 as well as from other trees belonging to the birch homologous group. The trial was designed to confirm the effect of treatment with the tree tablet as measured by improvement in allergy symptoms and reduction in allergy pharmacotherapy use during the 2022 and 2023 pollen seasons. ALK’s Executive Vice President of Research and Development, Henriette Mersebach, says: “With the outcome of this large clinical trial, we have now successfully completed our paediatric development of all of ALK’s sublingual AIT tablets in respiratory allergies. The study results are consistent with previous tablet trial results and clearly confirms the benefits of treating respiratory allergies with our AIT tablets already from early childhood. This positive outcome is also important for ALK’s long-term growth ambitions and our ability to transform the medical treatment of children with allergies.” 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. ALK will now pursue a dialogue with relevant regulatory authorities about expanding the current product indications. Subject to approval, the tree tablet could become available for young patients in Europe and Canada in 2025. ALK expects to present further details from the trial at a scientific congress in 2024. In line with ALK’s commitment to secure approvals for all of ALK’s respiratory tablets covering paediatric, adolescent, and adult use, ALK has also recently successfully completed a pivotal, Phase 3 paediatric trial with its house dust mite tablet (ACARIZAX®). 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 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 2,700 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net. Attachment FM_14_23UK_11102023

HAMBURG, Germany, June 11, 2023 /PRNewswire/ -- A study conducted by researchers from the ALL-MED Medical Research Institute and the Department of Clinical Immunology at Wroclaw Medical University in Poland has validated the use of an allergen exposure chamber (AEC) in assessing the clinical outcomes of house dust mite (HDM) allergen immunotherapy (AIT) in patients with allergic rhinoconjunctivitis. The study focused on evaluating the efficacy and safety of AEC-derived clinical outcomes of subcutaneous HDM AIT, a treatment designed to alleviate symptoms triggered by HDM allergies. Fifty patients with HDM-triggered allergic rhinoconjunctivitis were included in the study, with HDM allergy confirmed through various diagnostic tests such as skin prick tests, serum-specific IgE, and basophil activation tests. During the study, patients were assessed in the allergen exposure chamber before commencing AIT and after 12 months of treatment. The chamber provided a controlled environment, allowing patients to be exposed to HDM allergen under stable and well-regulated conditions. Various clinical endpoints, including total nasal symptom score (TNSS), visual analog scale (VAS), and objective parameters such as acoustic rhinometry, peak nasal inspiratory flow (PNIF), and nasal secretion weight, were used to assess the effectiveness of AIT. The results of the study demonstrated a statistically significant reduction in TNSS (p<0.005) after one year of AIT, indicating the positive impact of the treatment on nasal symptoms. There was a high reduction in nasal symptoms observed using other objective parameters (PNIF, nasal secretion, acoustic rhinometry-MCA). These findings suggest the potential of AEC as a valuable tool for data collection, proof-of-concept studies, and biomarker analysis. "The study findings demonstrate that the Allergen Exposure Chamber (AEC) challenge is consistent and safe, allowing researchers to collect data quickly and of high quality. Moreover, the results indicate that the clinical measurements obtained in the AEC align well with the effectiveness evaluation using the Combined Symptom and Medication Score (CSMS) in real-life conditions. This suggests that the AEC could serve as an alternative to traditional trial designs. Specifically, the Total Nasal Symptom Score (TNSS) measured in the AEC is identified as a reliable primary endpoint in clinical trials. However, nasal provocation tests (NPT) may not be suitable as a primary endpoint since they do not correlate well with CSMS in real-life conditions and TNSS in the AEC", says Professor Marek Jutel from Wroclaw. The researchers emphasize the importance of further validating clinical endpoints using immunological biomarkers for the continued development and application of AEC in clinical trials. The study also suggests that accelerated dose escalation of native HDM AIT is both safe and convenient. A movie on Allergen Chamber test is available here: In conclusion, the study confirms that the allergen exposure chamber challenge is an effective, reproducible, and safe method for assessing the outcomes of HDM AIT in patients with allergic rhinoconjunctivitis. Ongoing research is being conducted to validate clinical endpoints using immunological biomarkers, offering promising prospects for improved diagnostic and treatment approaches. About EAACI: The European Academy of Allergy and Clinical Immunology (EAACI) is an association of clinicians, researchers and allied health professionals founded in 1956. EAACI is dedicated to improving the health of people affected by allergic diseases. With more than 15 000 members from 125 countries and over 75 National Allergy Societies, EAACI is the primary source of expertise in Europe and worldwide for all aspects of allergy. Contact: EAACI Headquarters, Hagenholzstrasse 111, 3rd Floor 8050 Zurich, CH- Switzerland Tel: +41799561865 [email protected] Logo: SOURCE EAACI

BAAR, Switzerland--(BUSINESS WIRE)-- Stallergenes Greer, a biopharmaceutical company specialising in the diagnosis and treatment of respiratory allergies, announced today the initiation of a Phase III clinical study (YOBI, YOung patients and BIrch allergy) to confirm the safety and efficacy of Staloral® Birch in children and adolescents with birch pollen-induced allergic rhino-conjunctivitis with or without asthma. The randomised, double-blind placebo-controlled Phase III study will involve approximately 80 sites in 12 European countries. Allergic rhino-conjunctivitis is a worldwide disease and a global health burden affecting more than 500 million people, who are at higher risk of developing rhinitis exacerbation and asthma than the general population1..Birch is among the strongest allergy-producing trees in northern Europe. The allergic potential of other trees belonging to the birch homologous group, such as alder and hazel, is also increasing steadily2. In children and adolescents, allergic rhino-conjunctivitis can lead to sleep problems, fatigue, missed school days and can complicate outdoor activities3. Individuals sensitised at a young age are also more at risk of developing asthma. The younger the children are, the higher their risk of developing asthma, which highlights the relevance of early causal treatment in paediatric patients to slow the worsening of allergy symptoms4. Allergen immunotherapy (AIT) is currently the only available therapeutic treatment that has the potential to uniquely alter the natural course of the disease5. In its liquid form, sublingual AIT can provide a needle-free and flexible treatment for children and adolescents. “Allergic rhino-conjunctivitis induced by birch and related trees can lead to a spiraling of respiratory symptoms and conditions in the paediatric population. The YOBI study will contribute to addressing a global health burden, while deepening our knowledge of AIT with the aim of improving patient outcomes for children and adolescents with birch-induced allergies,” said Professor Oliver Pfaar, International Coordinator of the YOBI study, Head of Rhinology and Allergy, Department of Otorhinolaryngology, Philipps-Universität Marburg, Germany. “Stallergenes Greer’s AIT treatments have proven their efficacy and safety in both clinical trials and the real world,” stated Michele Antonelli, CEO of Stallergenes Greer. “This paediatric Phase III study, illustrates our determination to further develop evidence-based solutions and build on robust datasets and cutting-edge research technologies to advance precision medicine combined with dose adaptation for the benefit of patients with allergies, the medical community, and health systems.” ABOUT STALORAL® Staloral® is a sublingual solution of allergen extracts for AIT. It is indicated in the treatment of seasonal or perennial allergic rhinitis, rhino-conjunctivitis and mild to moderate allergic asthma in adults and, in certain territories, in the paediatric population (children over 5 years of age). Clinical evidence of the efficacy of Staloral® is globally consistent over the clinical studies Stallergenes Greer conducted versus placebo. The effectiveness of Staloral® as a causal treatment for allergic rhino-conjunctivitis beyond clinical trials was also assessed by Stallergenes Greer’s real-world studies EfficAPSI and BREATH (Bringing Real-World Evidence to Allergy Treatment for Health). ABOUT ALLERGIC RHINITIS/ALLERGIC RHINO-CONJUNCTIVITIS Allergic rhinitis/allergic rhino-conjunctivitis (AR/ARC) is a chronic disorder of the upper airways that is caused by allergen exposure and the resulting IgE-mediated inflammation of the nose and, to a less extent, the eyes. Allergic rhinitis can notably include symptoms such as sneezing, a runny nose, wheezing, cough, itching, and watery/itchy eyes. Symptoms may be severe and significantly impact the patient’s quality of life, as well as worsen over time with progression towards asthma4. First intention symptomatic treatments such as antihistamines and nasal corticosteroids provide temporary relief to patients. The primary therapeutic goals of AIT include reducing symptoms, reducing symptomatic medication use, and improving allergy-related quality of life. AIT achieves these goals and can alter the course of the disease, with benefits persisting in many patients for several years after treatment discontinuation6. ABOUT STALLERGENES GREER INTERNATIONAL AG Headquartered in Baar (Switzerland), Stallergenes Greer International AG is a global healthcare company specialising in the diagnosis and treatment of allergies through the research, development and commercialisation of allergen immunotherapy products and services. Stallergenes Greer International AG is the parent company of Greer Laboratories, Inc. (whose registered office is in the United States) and Stallergenes SAS (whose registered office is in France). For more information, visit . 1. Bousquet, J., et al., Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy, 2008. 63 Suppl 86: p. 8-160. 2. Biedermann, T., et al., Birch pollen allergy in Europe. Allergy, 2019. 74(7): p. 1237-1248. 3. Canonica GW, Bousquet J, Mullol J, Scadding GK, Virchow JC. A survey of the burden of allergic rhinitis in Europe. Allergy. 2007;62 Suppl 85:17-25. doi:10.1111/j.1398-9995.2007.01549.x 4. Klimek, L., et al., ARIA guideline 2019: treatment of allergic rhinitis in the German health system. Allergo journal international, 2019. 28(7): p. 255-276. 5. Roberts G, Pfaar O, Akdis CA, et al. EAACI Guidelines on Allergen Immunotherapy: Allergic rhinoconjunctivitis. Allergy. 2018;73(4):765-798. doi:10.1111/all.13317 6. Hesse, L., et al., Allergen immunotherapy for allergic airway diseases: Use lessons from the past to design a brighter future. Pharmacology & Therapeutics, 2022: p. 108115.