New Adaptive Trial Design Supports Evaluation of Therapeutic Strategies for Allergic Patients

New Adaptive Trial Design Supports Evaluation of Therapeutic Strategies for Allergic Patients

Hamburg, June 11 – Allergic rhinitis (AR) and rhinoconjunctivitis, common chronic inflammatory allergic diseases affecting the upper respiratory tract, have a significant impact on the global population. The prevalence of AR ranges from 17% to 29% in Europe and up to 20% in the United States, with seasonal allergic rhinitis (SAR) affecting up to 40% of children. While current treatment strategies mainly focus on symptom relief, allergen immunotherapy (AIT) has shown promise in inducing clinical and immunological tolerance. A new adaptive trial design aims to evaluate the effectiveness 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 chemical modification using glutaraldehyde cross-linking. This modification reduces allergenicity while maintaining important immunological properties. The allergoid is further enhanced with an adjuvant system to stimulate the immune response effectively.

In a recent Phase II study, PQ Grass demonstrated a significant dose-response relationship in reducing symptoms, leading to the identification of the optimally effective and safe cumulative dose of 27,600 standardised units (SU). Building 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 across 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 an active placebo or saline. The primary efficacy endpoint was the CSMS averaged over the peak grass pollen season (GPS).

The results of the trial demonstrated a significant improvement in the CSMS for both the PQ Grass extended and conventional regimens 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 the total combined score (TCS).

“These findings highlight the potential of PQ Grass as an effective therapeutic option for allergic patients. The adaptive trial design utilized in this study enables a more efficient evaluation of treatment strategies, providing valuable insights into the clinical and immunological effects of novel 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,” says EAACI VP Congresses, Professor of Immunology and Allergy of Imperial College London Mohamed Shamji.

Further research and clinical studies will be conducted to confirm the safety and efficacy of PQ Grass. If approved, this innovative therapeutic approach could significantly impact the management of allergic rhinitis and rhinoconjunctivitis, offering a potential cure for patients suffering from these chronic allergic conditions.

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