Allergy Therapeutics plc (LON:AGY) the fully integrated specialty pharmaceutical company specialising in allergy vaccines, research and development director Tim Higgenbottam talks to DirectorsTalk about ATL US dose ranging study, provides an update, talks safety signals, findings and how the study been received by the US allergists and their staff.
On Thursday Allergy Therapeutics plc announced it has completed patient enrollment for its Phase IIb dose-finding study, G204, in the US. GrassMATAMPL is an ultra-short course subcutaneous allergen specific immunotherapy (“SCIT”) administered prior to the grass pollen season. Total patient enrolment for the Phase IIb study was 250 patients and headline data is expected at the end of the first half of 2016, paving the way for the US Phase III study.
GrassMATAMPL is developed from Allergy Therapeutics’ successfully marketed Pollinex Quattro Grass product and is a unique adjuvanted SCIT in which a grass allergen extract is chemically modified to form a standardised allergen (‘allergoid’) preparation. This is bound to microcrystalline tyrosine (“MCT”) and combined with the adjuvant Monophosphoryl lipid A (MPL), enabling the reduction of allergenicity whilst maintaining immunogenicity. The product design allows for an effective cumulative dose to be attained in up to six weeks, avoiding continuous administration, as required by conventional SCIT products, over a year or more. The SCIT market in the US is worth approximately $2 billioni.
G204 is a dose-finding study using, for the first time, two mobile environmental exposure chambers based in Cincinnati and in New Jersey Shore. The chambers are inflatable laboratories that enable subjects with grass pollen allergy to be exposed to a constant concentration of pollen for periods of three hours over four consecutive days. Their great advantage is that they can be used outside of the grass pollen season for accurate dose selection studies.
The G204 study was preceded by a safety study, G102, of two new higher doses of GrassMATAMPL compared with placebo, which completed on 22 October 2015. No systemic adverse events were seen in this study with only mild local reactions to the injections.
