Allergy Therapeutics announces findings from mEEC dose range finding study G204

A further dose range finding study will be implemented prior to proceeding into the planned pivotal Phase III study. GrassMATAMPL is an ultra-short course subcutaneous allergen specific immunotherapy ("SCIT") administered prior to the grass pollen season.

Based on the successful dose response data identified in the Phase II G203 study for the same US GrassMATAMPL programme, the G204 trial was designed to explore higher dose regimens using the novel technology of the mEEC (mobile environmental exposure chamber) and optimise the recommended dose before starting the pivotal Phase III trial (G306) to be performed in the US.

In contrast to the G203 study, the dose range finding data with the mEEC did not allow the Company to recommend an optimised dose regime to take into Phase III studies for the US.

Consequently, Allergy Therapeutics will undertake a further dose-ranging study employing the same successful European dose-finding trial design with a fixed Conjunctival Provocation Test (CPT) which provided robust results for the optimisation of the Company’s marketed subcutaneous birch pollen product, Pollinex® Quattro Birch (PQBirch).

The next dose range finding study is planned to start in 2017. Allergy Therapeutics will await the outcome of an End of Phase II meeting with the FDA, scheduled later in 2016, before progressing into Phase III.

Commenting on the announcement, Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "Defining the optimal dose is part of late-stage product development and we will revisit dose evaluation as we recently successfully did with our PQ Birch product, using two separate and complimentary dose-ranging studies.

"Additionally, the new findings of our Phase II EEC study will need to be discussed with FDA before deciding on the recommended dose for the following Phase III registration trial. While still being determined to become the first company to introduce SCIT to the US, a deferred entry time into the market is now anticipated.

"In Europe, our market penetration continues to accelerate, outperforming the market with 19% year-to-date revenue growth*, an increase from the 12% revenue growth* we had achieved in December 2015.

"Elsewhere in the pipeline, we successfully completed a Phase IIb dose finding study for Pollinex Quattro Birch in Germany and Austria earlier this year; we’ve completed the exploratory dose finding study in the US; set up the protocols for the Acarovac Quattro programme in Spain; and we have initiated the proof-of-concept plan for the VLP Peanut allergy vaccine in Switzerland.

"We are progressing with our plans and are very excited by the prospects of building a leading subcutaneous company in Europe as well as in international markets."