Allergy Therapeutics

Innovative G309 exploratory grass trial starts

Lighthouse | 26 October 2020

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  • Allergy Therapeutics has announced the screening of the first patient in the G309 exploratory field study of Grass MATA MPL, a short course, aluminium-free, allergen-specific, subcutaneous immunotherapy (SCIT), in seasonal allergic rhinitis and/or rhinoconjunctivitis induced by grass pollen.
  • G309 is a double-blind, placebo controlled, randomised study designed to evaluate the efficacy and safety of an optimized Phase III dose of 27,600 SU Grass MATA MPL. The trial will run for one year, capturing the 2020/21 allergy season, and recruit c 150 patients over 12 sites in Germany and the US. The primary endpoint is the combined symptom medication score (CSMS) averaged over the peak grass pollen season.
  • Full details of the G309 protocol have not been disclosed, as they are understood to be highly innovative and based on cutting edge concepts in the allergy field developed by Allergy Therapeutics. The aim of this is to mitigate risk and optimise SCIT trial results, as the difficulty of replicating results seen in Phase II allergy immunotherapy studies in multinational, multi-centre Phase III trials, with possibly slightly different endpoints, is a recognised problem across the industry.
  • However, it is known that the G309 the trial will, for the first time in a SCIT study, include evaluation of several different placebo options (including saline), combine several Phase II and Phase III endpoints to support the validation of the regulatory mandated primary endpoint, and includes extensive biomarker analysis.
  • Data from G309 are expected in H221 and will help inform and optimise the design of the pivotal Phase III study (G306), required for FDA filing and potential US approval. G306 will also be run in Europe and the US, and is expected to start in H222, over the 2022/23 allergy season.

Trinity Delta view: The start of Allergy Therapeutics’s G309 Grass MATA MPL trial is a defining step for the company. It will be used to inform the G306 pivotal trial that will support US approval, using the company’s significant experience and know-how to mitigate the risks inherent in Phase III allergy trials, and will also provide an archetype for subsequent Phase III trials for other MATA MPL assets (including birch and ragweed). The Grass MATA MPL Phase III programme will provide the clinical data to support regulatory approval in Europe and the US. In the former region, this approval will broaden prescribing beyond ‘named patient’ basis; in the US, Grass MATA MPL will likely become the first short-course, subcutaneous, and aluminium-free grass allergy therapy available. We currently value Allergy Therapeutics at £325m (51p/share), based on sum of the parts including a DCF of the commercial operations (£87m or 14p/share), an rNPV of the R&D pipeline (£204m, or 32p/share), and net cash.


26 October 2020

Market Cap£87.6m
Primary exchangeAIM
Company CodeAGY
Corporate clientYes

Company description

Allergy Therapeutics specialises in the diagnosis and treatment of allergy. The existing European business generates c £80m annual sales. Near-term R&D efforts are focussed on the Pollinex Quattro platform, whilst in the medium-term the VLP platform is highly promising.


Lala Gregorek
+44 (0) 20 3637 5043

Franc Gregori
+44 (0) 20 3637 5041


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