Date: 2015-07-12
Type of information: Initiation of patient enrollment
phase: 2
Announcement: initiation of patient enrollment
Company: Allergy Therapeutics (UK)
Product: Grass MATA MPL
Action
mechanism: immunotherapy product. GMM is developed from Allergy Therapeutics’ successfully marketed Pollinex Quattro Grass product, which has been available in Europe for a number of years treating circa 250,000 patients1, and is designed to provide a uniquely ultra-short course of injections to prevent seasonal grass allergy.
Disease: grass allergic rhinitis
Therapeutic area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Country: USA
Trial
details: There is increasing evidence that the effectiveness of allergy immunotherapy to control symptoms of rhinoconjunctivitis is related to the cumulative dose of allergen or allergoid administered during a single regimen of subcutaneous (SC) injections or of sublingual administration. The current therapeutic dose regimen for Grass MATA MPL is a course of four injections of 300, 800, 2000 and 2000 SU (Standardized Units), administered at weekly intervals (cumulative dose 5100 SU). Two new cumulative doses of the Grass MATA MPL 10200 SU and 18200 SU are being developed to compare with the current dose. The study is designed to explore the benefit/risk of increasing the cumulative allergen dose of the Grass MATA MPL immunotherapy comparing these doses with the current dose of Grass MATA MPL, Grass MATA (without MPL) and placebo. (NCT02582073)
Latest
news: * On July 12, 2015, Allergy Therapeutics announce enrolment of the first ten US patients in the Company’s GrassMATAMPL (“GMM”) 204 phase II study (G204). G204 is a double-blind, placebo-controlled cumulative dose selection study for grass allergic rhinitis, which follows the successful completion of the GMM102 (G102) safety study, which demonstrated safety of two new doses of GMM and supports the further testing of efficacy in the current G204 study. The G204 phase II study has been agreed with the FDA, is expected to read out in the second quarter of 2016, and precedes the initiation of the pivotal phase III study for US approval.
