Hay fever vaccine specialist Allergy Therapeutics (LON:AGY) has enrolled its first patients in a US phase II trial of its grass allergic rhinitis product GMM.
Results from the double-blind, placebo-controlled cumulative dose selection study are due in the second quarter of 2016 ahead of a phase III study for US approval in 2018.
GMM has been developed from Allergy Therapeutics’ Pollinex Quattro Grass product, which has been available in Europe for some years already.
Up to 50% of the US suffers from inflammation and sneezing associated with seasonal allergic rhinitis/conjunctivitis, which Allergy says is poorly controlled by anti-leukotrienes and nasal corticosteroids.
Manuel Llobet, Allergy’s chief executive, 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 sub-cutaneous vaccine, which we are striving to achieve, will facilitate a fast penetration and broad acceptance of the product among the prescriber base."