Short-course subcutaneous treatment with PQ Grass strongly improves symptom and medication scores in grass allergy

P J de Kam; S Zielen; J A Bernstein; U Berger; M Berger; M Cuevas; D Cypcar; A Fuhr-Horst; W A Greisner; M Jandl; S Laßmann; M Worm; J Matz; E Sher; C Smith; G C Steven; R Mösges; M H Shamji; L DuBuske; F Borghese; K Oluwayi; T Zwingers; M Seybold; O Armfield; M D Heath; S J Hewings; M F Kramer; M A Skinner

doi:10.1111/all.15788

Short-course subcutaneous treatment with PQ Grass strongly improves symptom and medication scores in grass allergy

Allergy. 2023 Oct;78(10):2756-2766. doi: 10.1111/all.15788. Epub 2023 Jun 27.

Authors

P J de Kam¹, S Zielen², J A Bernstein³, U Berger⁴, M Berger⁵, M Cuevas⁶, D Cypcar⁷, A Fuhr-Horst⁸, W A Greisner⁹, M Jandl¹⁰, S Laßmann¹¹, M Worm¹², J Matz¹³, E Sher¹⁴, C Smith¹⁵, G C Steven¹⁶, R Mösges^{17

18}, M H Shamji^{19

20}, L DuBuske²¹, F Borghese¹, K Oluwayi¹, T Zwingers¹, M Seybold¹, O Armfield¹, M D Heath¹, S J Hewings¹, M F Kramer¹, M A Skinner¹

Affiliations

¹ Allergy Therapeutics PLC, Worthing, UK.
² Children and Adolescents Department, Allergology, Pulmonology & Cystic Fibrosis, Goethe University, Frankfurt, Germany.
³ Bernstein Clinical Research Center, LLC, Cincinnati, Ohio, USA.
⁴ Aerobiology and Pollen Research Unit, Department of Oto-Rhino-Laryngology, Medical University Vienna, Vienna, Austria.
⁵ Department of Otorhinolaryngology, Wiener Gesundheitsverbund, Hospital Hietzing, Vienna, Austria.
⁶ Clinic and Polyclinic of Otorhinolaryngology, University Clinic Carl Gustav Carus, Dresden, Germany.
⁷ Allergy Partners of Western North Carolina, Asheville, North Carolina, USA.
⁸ ENT Research- Institut für klinische Studien, Essen, Germany.
⁹ Bluegrass Allergy Research, Lexington, Kentucky, USA.
¹⁰ Hamburger Institut für Therapieforschung GmbH, Hamburg, Germany.
¹¹ Studienzentrum Dr. Sabine Laßmann, Saalfeld, Germany.
¹² Department of Dermatology and Allergy-Charite Campus Mitte, Universitätsmedizin Berlin, Berlin, Germany.
¹³ Chesapeake Clinical Research, Inc, White Marsh, Maryland, USA.
¹⁴ Allergy Partners of New Jersey, Ocean Township, New Jersey, USA.
¹⁵ Certified Research Associates, Cortland, New York, USA.
¹⁶ Allergy Asthma & Sinus Center, S.C., Greenfield, Wisconsin, USA.
¹⁷ IMSB (Institute of Computational Biology and Medical Statistics), University at Cologne, Cologne, Germany.
¹⁸ ClinCompetence, Cologne, Germany.
¹⁹ Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Department of National Heart and Lung Institute, Imperial College London, London, UK.
²⁰ Asthma UK Centre in Allergic Mechanisms of Asthma, Imperial College London, London, UK.
²¹ Division of Allergy and Immunology, Department of Internal Medicine, George Washington University Hospital, Washington, DC, USA.

PMID: 37366581
DOI: 10.1111/all.15788

Abstract

Background: A modified grass allergen subcutaneous immunotherapy (SCIT) product with MicroCrystalline Tyrosine and monophosphoryl lipid-A as an adjuvant system (Grass MATA MPL [PQ Grass]) is being developed as short-course treatment of grass-pollen allergic rhinitis (SAR) and/or rhinoconjunctivitis. We sought to evaluate the combined symptom and medication score (CSMS) of the optimized cumulative dose of 27,600 standardized units (SU) PQ Grass in a field setting prior to embarking on a pivotal Phase III trial.

Methods: In this exploratory, randomized, double-blind, placebo-controlled trial subjects were enrolled across 14 sites (Germany and the United States of America). Six pre-seasonal subcutaneous injections of PQ Grass (using conventional or extended regimens) or placebo were administered to 119 subjects (aged 18-65 years) with moderate-to-severe SAR with or without asthma that was well-controlled. The primary efficacy endpoint was CSMS during peak grass pollen season (GPS). Secondary endpoints included Rhinoconjunctivitis Quality of Life Questionnaire standardized (RQLQ-S) and allergen-specific IgG4 response.

Results: The mean CSMS compared to placebo was 33.1% (p = .0325) and 39.5% (p = .0112) for the conventional and extended regimens, respectively. An increase in IgG4 was shown for both regimens (p < .01) as well as an improvement in total RQLQ-S for the extended regimen (mean change -0.72, p = .02). Both regimens were well-tolerated.

Conclusions: This trial demonstrated a clinically relevant and statistically significant efficacy response to PQ Grass. Unprecedented effect sizes were reached for grass allergy of up to ≈40% compared to placebo for CSMS after only six PQ Grass injections. Both PQ Grass regimens were considered equally safe and well-tolerated. Based on enhanced efficacy profile extended regime will be progressed to the pivotal Phase III trial.

Keywords: allergic rhinoconjunctivitis; grass pollen allergy; short-course treatment; subcutaneous immunotherapy.

Grants and funding

Allergy Therapeutics