HAL Allergy has successfully completed its Phase III short-term efficacy trial with its sublingual allergen immunotherapy (SLIT) liquid product for the treatment of birch pollen allergy.
The positive results of this pivotal study will support HAL Allergy to obtain full marketing authorization of this product from the Paul Ehrlich Institute (PEI) in Germany and subsequently in other European countries.
Leiden, The Netherlands, 17th of May 2016 – HAL Allergy has successfully completed its allergen specific immunotherapy Phase III trial with its sublingual immunotherapy (SLIT) liquid product for treatment of birch pollen allergy. The Phase III trial was a randomized, double-blind, placeco-controlled, multi-centre study conducted in five European countries. 406 adult patients suffering from birch pollen induced allergic rhinitis/rhinoconjunctivitis with or without mild to moderate asthma were randomized into the trial. The treatment was started 3-6 months prior to the birch pollen season of 2015 and continued during the season. The primary efficacy parameter was the combined symptom and medication score (CSMS) as recommended in the position paper of the European Academy of Allergy and Clinical Immunology (EAACI).
The primary endpoint of the trial, defined as the difference in mean CSMS between active versus placebo was met. The CSMS score of the patients treated with the SLIT therapy was reduced by 31% (p<0.0001) as compared to the placebo treated group. The frequency and nature of the adverse reactions observed in the study were comparable to those observed in previous studies with this SLIT product and to those observed with similar products. Therefore, the efficacy and safety of short-term treatment with the SLIT product for birch pollen allergy is considered to be established. HAL Allergy moves forward to submit the registration dossier for this product to the Paul Ehrlich Institute in Germany for full marketing authorization and will subsequently pursue marketing approval in other European countries.
‘’HAL Allergy is the first company to announce favourable results from a Phase III study performed under the therapy allergens ordinance (Therapieallergene-Verordnung) in Germany. The results confirm the efficacy and safety of our sublingual allergen immunotherapy. With this we will be able to provide a therapy to patients suffering from birch and spring tree pollen allergies.’’ says Dr. Harry Flore, CEO of HAL Allergy.
About allergic rhinitis
Allergic diseases have become a pandemic health problem and pose a major challenge to Western medicine. Conservative estimates suggest that approximately half a billion people worldwide suffer from allergic rhinitis. Pollen allergens are considered a major risk factor for both seasonal allergic rhinitis and bronchial asthma, constituting 20% and 8% of the population, respectively. Moreover, the prevalence of pollen allergy has risen to an estimated 40% in the past decades and among tree pollen allergies, birch (Betula) is one of the major pollen allergen-producing trees. It has been shown that the prevalence of subjects with a positive skin prick test (SPT) to birch pollen allergen is as high as 54% of the general population in some regions of Europe. Therefore, the liquid SLIT preparation for treatment of birch pollen allergy will be a relevant treatment option, which can relieve allergic rhinitis symptoms and improve quality of life, and potentially modifying the underlying disease.
About HAL Allergy
HAL Allergy Group is active in the field of biopharmaceuticals and is located at the Bio Science Park in Leiden, The Netherlands. Our core business is the development and manufacturing of therapies and diagnostics for allergic diseases. In addition, we offer contract manufacturing services focusing on the production of biopharmaceutical products for (pre-) clinical studies. With offices in major European countries, HAL Allergy is one of the European top players in the allergy immunotherapy business. Established in 1959 HAL Allergy has long experience in developing, producing and selling allergy therapies with an immuno-modulatory effect causing a reduction in symptoms and long-term disease suppression. The allergy therapies are used against common allergies such as hay fever, house dust mites allergy and allergic reactions towards wasp or bee stings. More information is available on: http://www.hal-allergy.com.
The main shareholder of HAL Allergy GmbH is Droege International Group AG, which is an independent Advisory and Investment Company, based in Düsseldorf, Germany. More information is available on: http://www.droege-group.com.
HAL Allergy Group
Manager Corporate Communications
Tel. + 31 (0)88 1959010