Allergy Thera. Regulatory News (AGY)

7 December 2015

Allergy Therapeutics plc

("Allergy Therapeutics" or the "Company")

US Phase II study for GrassMATAMPL initiated

Headline data expected Q2 2016; US clinical development plans on track

Allergy Therapeutics, the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces 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."

References

1 Allergy Therapeutics Data

2 DataMonitor Epidemiology - Epidemiology Allergic Rhinitis -March 2011

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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 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 in total will be studied before and after treatment.

The first patients have 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 and no significant adverse events were reported with the new dose regimens that are being used in G204.