- 2023 Annual Congress of the European Academy of Allergy and Clinical Immunology: A new adaptive trial design supports the evaluation of therapeutic strategies for allergic patients
HAMBURG, Germany, June 11, 2023 /PRNewswire/ -- Allergic rhinitis (RA) and rhinoconjunctivitis, common chronic inflammatory allergic diseases affecting the upper respiratory tract, have a significant impact on the world's population. The prevalence of AR ranges from 17 to 29% in Europe and up to 20% in the United States, and seasonal allergic rhinitis (SAR) affects up to 40% of children. While current treatment strategies focus primarily on symptom relief, allergen immunotherapy (AIT) has shown promise in inducing clinical and immunological tolerance. A new adaptive trial design aims to evaluate the efficacy of a modified short-course subcutaneous immunotherapy (SCIT) product, PQ Grass, in addressing the unmet needs of allergic patients.
PQ Grass is a novel therapeutic approach consisting of a modified SCIT product that combines an extract of 13 different grass pollens with a chemical modification through glutaraldehyde cross-linking. This modification reduces allergenicity while maintaining important immunological properties. The allergoid is further enhanced with an adjuvant system to effectively stimulate the immune response.
In a recent Phase II study, PQ Grass demonstrated a significant dose-response relationship in symptom reduction, leading to the identification of the safe and optimally effective cumulative dose of 27,600 standardized units (SU). Based on these promising results, an exploratory phase III trial was conducted to evaluate the combined symptom and medication score (CSMS) of PQ Grass compared to placebo.
The trial employed a randomized, parallel-group, double-blind, placebo-controlled design at 14 sites in the United States and Germany. Subjects were randomized into four treatment groups, including two PQ Grass groups receiving either a conventional or extended regimen, and two placebo groups receiving active placebo or saline. The primary efficacy endpoint was CSMS averaged over the peak grass pollen season (GPS).
The results of the trial demonstrated a significant improvement in the CSMS for the extended and conventional regimens of PQ Grass compared to placebo, with relative reductions of 39.5 and 33.1%, respectively. This translates to an absolute reduction in symptoms of 0.67 and 0.56 points compared to placebo. The PQ Grass extended regimen also showed a significant improvement in total combined score (TCS).
"These findings highlight the potential of PQ Grass as an effective therapeutic option for allergic patients. The adaptive trial design used in this study allows for more efficient evaluation of treatment strategies, providing valuable insight into clinical and immunological effects." of new therapies. The results support the continued development of PQ Grass and its potential to address the unmet needs of allergic patients by offering a short-course SCIT treatment option," explained Mohamed Shamji, EAACI Vice President of Congresses, Professor Immunology and Allergy at Imperial College London.
Further research and clinical studies will be carried out to confirm the safety and efficacy of PQ Grass. If approved, this innovative therapeutic approach could have a significant impact in the treatment of allergic rhinitis and rhinoconjunctivitis, offering a potential cure for patients suffering from these chronic allergic conditions.
About EAACI:
The European Academy of Allergy and Clinical Immunology (EAACI) is an association of physicians, researchers and allied health professionals founded in 1956. EAACI is dedicated to improving the health of people affected by allergic diseases. With more than 13,000 members from 125 countries and more than 75 National Allergy Societies, EAACI is the leading source of expertise in Europe and worldwide for all aspects of allergy.
Contact: EAACI headquarters, Hagenholzstrasse 111, 3rd - 8050 Zurich, CH- Switzerland Tel: 41799561865 communications@eaaci.org www.eaaci.org
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