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

P J. de Kam, Allergy Therapeutics PLC, Worthing, UK.
S Zielen, Children and Adolescents Department, Allergology, Pulmonology & Cystic Fibrosis, Goethe University, Frankfurt, Germany.
J A. Bernstein, Bernstein Clinical Research Center, LLC, Cincinnati, Ohio, USA.
U Berger, Aerobiology and Pollen Research Unit, Department of Oto-Rhino-Laryngology, Medical University Vienna, Vienna, Austria.
M Berger, Department of Otorhinolaryngology, Wiener Gesundheitsverbund, Hospital Hietzing, Vienna, Austria.
M Cuevas, Clinic and Polyclinic of Otorhinolaryngology, University Clinic Carl Gustav Carus, Dresden, Germany.
D Cypcar, Allergy Partners of Western North Carolina, Asheville, North Carolina, USA.
A Fuhr-Horst, ENT Research- Institut für klinische Studien, Essen, Germany.
W A. Greisner, Bluegrass Allergy Research, Lexington, Kentucky, USA.
M Jandl, Hamburger Institut für Therapieforschung GmbH, Hamburg, Germany.
S Laßmann, Studienzentrum Dr. Sabine Laßmann, Saalfeld, Germany.
M Worm, Department of Dermatology and Allergy-Charite Campus Mitte, Universitätsmedizin Berlin, Berlin, Germany.
J Matz, Chesapeake Clinical Research, Inc, White Marsh, Maryland, USA.
E Sher, Allergy Partners of New Jersey, Ocean Township, New Jersey, USA.
C Smith, Certified Research Associates, Cortland, New York, USA.
G C. Steven, Allergy Asthma & Sinus Center, S.C., Greenfield, Wisconsin, USA.
R Mösges, IMSB (Institute of Computational Biology and Medical Statistics), University at Cologne, Cologne, Germany.
M H. Shamji, Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Department of National Heart and Lung Institute, Imperial College London, London, UK.
L DuBuske, Division of Allergy and Immunology, Department of Internal Medicine, George Washington University Hospital, Washington, DC, USA.
F Borghese, Allergy Therapeutics PLC, Worthing, UK.
K Oluwayi, Allergy Therapeutics PLC, Worthing, UK.
T Zwingers, Allergy Therapeutics PLC, Worthing, UK.
M Seybold, Allergy Therapeutics PLC, Worthing, UK.
O Armfield, Allergy Therapeutics PLC, Worthing, UK.
M D. Heath, Allergy Therapeutics PLC, Worthing, UK.
S J. Hewings, Allergy Therapeutics PLC, Worthing, UK.
M F. Kramer, Allergy Therapeutics PLC, Worthing, UK.
M A. Skinner, Allergy Therapeutics PLC, Worthing, UK.

Document Type

Journal Article

Publication Date

6-27-2023

Journal

Allergy

DOI

10.1111/all.15788

Keywords

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

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.

Department

Medicine

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