Allergy Therapeutics, the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today told DirectorsTalk about the 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.
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. Grass allergy occurs in up to 50% of the US population2 of those suffering from seasonal allergic rhinitis/conjunctivitis, and is often poorly controlled by anti-leukotrienes and nasal corticosteroids.
Manuel Llobet, CEO of Allergy Therapeutics, said: “The US clinical development programme for our ultra-short course, aluminium-free allergy vaccine for grass remains on track. We continue to expect to file for US approval at the end of 2018. The US allergy immunotherapy market has historically been serviced by subcutaneous rather than sublingual compounded vaccines. We are therefore confident that the availability of an FDA-approved subcutaneous vaccine, which we are striving to achieve, will facilitate a fast penetration and broad acceptance of the product among the prescriber base.”
