Allergy Thera. Regulatory News (AGY)

18 February 2016

Allergy Therapeutics plc

 ("Allergy Therapeutics" or the "Company")

Patient enrolment completed in US Phase IIb study of GrassMATAMPL

Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces it has completed patient enrolment 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.

Tim Higenbottam, Research & Development Director of Allergy Therapeutics, said:

"We have completed recruitment in the G204 US study within schedule., We are confident that the results will build on the previous positive data for our MATAMPL studies and, combined with the commercial success of Pollinex Quattro in Europe, this will prepare the ground for entry in to the high value US market. GrassMATAMPL has the potential to become the best in class ultra-short course SCIT in the US market and we look forward to reporting headline data at the end of the first half of 2016." 

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Ends -

Allergy Therapeutics +44 (0) 1903 845 820

Manuel Llobet, Chief Executive Officer

Ian Postlethwaite, Finance Director

Panmure Gordon +44 (0) 20 7886 2500

Freddy Crossley / Peter Steel / Duncan Monteith, Corporate Finance

Tom Salvesen, Corporate Broking

Consilium Strategic Communications +44 20 3709 5700

Mary-Jane Elliott / Ivar Milligan / Matthew Neal / Laura Thornton

Allergytherapeutics@consilium-comms.com

Notes for editors

About Allergy Therapeutics

Allergy Therapeutics is a specialty pharmaceutical company focused on allergy vaccination. It has a growing business achieving revenue in the last financial year of £43.2 million mainly in Europe through its own sales and marketing infrastructure and further afield through distributors.

About Pollinex Quattro

Pollinex Quattro is a unique allergen-specific immunotherapy that comprises three key technologies tailored to reduce irritation and systemic reactions; modified allergens, microcrystalline tyrosine (MCT) and Monophosphoryl lipid A (MPL). The ultra-short duration of Pollinex Quattro is achieved via allergen modification that transforms the structure of allergens to allow increased doses to be delivered compared to traditional unmodified preparations. The potent depot adjuvant, MCT, has a Th1 immunomodulating action that acts in synergy with the TLR4 receptor agonist MPL to augment a shift in the immune reactions responsible for the symptoms of allergic rhinitis.

The study G204

The G204 study is the first to use multiple mobile Environmental Exposure Chambers providing constant pollen exposure to allergic patients, which is ideal for dose selection studies. The chambers are located in Cincinnati and New Jersey where 250 patients were studied before and after treatment.

The first patients successfully completed the screening phase of the study and were randomised to treatment on the 1 December 2015. A safety study G102 had been completed on the 20th of October 2015 and no significant adverse events were reported with the new dose regimens that were used in G204.