Allergy Thera. Regulatory News (AGY)

30 November 2015

Allergy Therapeutics plc

("Allergy Therapeutics" or the "Company")

Completion of patient enrolment in PQBirch204 Phase II study

Headline data expected in Q2 2016

Allergy Therapeutics, the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces that it has completed randomisation with 364 patients entered into the PQBirch204 double-blind, placebo-controlled dose selection study for the specific subcutaneous immunotherapy (SCIT), Pollinex Quattro Birch. The target sample size of 350 patients randomised into 6 dosage arms and placebo has been successfully achieved, ending the recruitment phase of this study. PQBirch204 is planned to complete by February, 2016 with results available in Q2 2016.

The endpoint of the trial is change in total rhynoconjunctival system score over baseline compared to placebo. The dose established as most efficacious, safe and tolerable will be selected and studied in the PQBirch phase III study, due to start in Q1 2017. The completion of the phase III study is expected to fulfil the requirements for the initial clinical programme under the Therapy Allergens Ordinance of the Paul Ehrlich Institute, the European Biologics Agency, and lead to Marketing Authorisation Approval of this SCIT in 2019.

Manuel Llobet, CEO of Allergy Therapeutics, said:

"We are excited to be progressing development for another potential product in our ultra-short course, aluminium-free Pollinex Quattro portfolio. This Phase II trial for treatment for birch pollen allergy should read out in the second quarter 2016 and will determine the dose for a subsequent pivotal trial in this setting, which is earmarked to begin at the beginning of 2017. Allergy to birch pollen is a significant health issue with around 6% of the population in Europe being skin-prick positive for the allergen."

About Allergic Rhinitis

Allergic rhinitis and conjunctivitis affects between 10% and 30% of the population worldwide1. Symptoms can be intrusive and debilitating and can include watery eyes, runny nose and inflammation. Current first line treatments such as antihistamines and corticosteroids lead to insufficient symptom control and add to the economic and patient burden. Currently, specific immunotherapy is the only known treatment that addresses the underlying cause of symptoms.

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.

References:

1 - World Health Organization. White Book on Allergy 2011-2012 Executive Summary. By Prof. Ruby Pawankar, MD, PhD, Prof. Giorgio Walkter Canonica, MD, Prof. Stephen T. Holgate, BSc, MD, DSc, FMed Sci and Prof. Richard F. Lockey, MD

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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.