Allergy Therapeutics starts field study in advance of pivotal Phase III Grass trial

Allergy Therapeutics plc (LON:AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, has announced the screening of the first patient in its exploratory field study (G309) to evaluate the efficacy and safety of Grass MATA MPL in subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis induced by grass pollen exposure. Grass MATA MPL is a short course, aluminium-free allergen-specific immunotherapy that aims to address the cause of symptoms of allergic rhinoconjunctivitis due to grass pollen.

This double-blind, placebo controlled, randomised study will run for one year and involve approximately 150 patients over 12 sites across Germany and the USA. The primary objective of this exploratory field study is to evaluate the safety and efficacy of its optimized Phase III dose of 27,600 SU Grass MATA MPL on grass pollen-induced rhinoconjunctivitis. The primary endpoint is the combined symptom medication score (CSMS) averaged over the peak grass pollen season. Results from the study will provide valuable information in preparation of the pivotal Phase III study (G306).

The breakthrough study design brings state of the art learnings in field trial methodology to the allergy immunotherapy research field. It is not only designed to evaluate safety and efficacy but is the first subcutaneous immunotherapy (SCIT) study to evaluate different placebo options, including normal saline. Moreover, the study combines several Phase II and Phase III endpoints to support the validation of the regulatory mandated primary endpoint and includes extensive biomarker analysis. These data aim to drive forward and underpin success in subsequent phase III trials for the Group’s whole MATA MPL programme including grass, birch and ragweed.

The Group, which has mitigation strategies in place to ensure the Grass MATA MPL clinical development programme continues despite the COVID-19 situation, expects results from the field study in H2 2021.

Manuel Llobet, CEO at Allergy Therapeutics, stated: “This exploratory grass trial will drive study design innovation in the allergy field and is an important intermediate step for the optimisation of our upcoming pivotal Phase III grass field trial, which will maximise the chances of success and entry into the US market. Parts of this protocol are ground-breaking and have the potential to significantly enhance science in this area.”

Click to view all articles for the EPIC:
Or click to view the full company profile:
Facebook
Twitter
LinkedIn
Allergy therapeutics plc

More articles like this

Online group supports parents coping with child allergies

A mother has set up a support group for parents coping with child allergies, offering them a “safe place to share”. Mother-of-two Claire Stone, from Thorndon, Suffolk, started Pippa Friendly to help other families in the

Beware of ‘thunder fever

Doctors today warned asthmatics and hay fever sufferers face a higher risk of deadly allergic reactions due to the current thunderstorms. The combination of high pollen counts and wet weather creates a phenomenon known as ‘thunder

Are allergies hereditary?

Introducing your kid to new foods should be a fun experience, but there’s a hidden danger that can make taste-testing a disaster: anaphylaxis, or a severe allergic reaction. Many allergies are mild and only result in

Parents warn of allergen danger after takeaway death

The parents of a teenager who died from an allergic reaction to a takeaway meal have said they want to help save lives by telling their daughter’s story. Megan Lee, 15, suffered irreversible brain damage after

Charity says 10 severe reactions can strike at any time

Allergies can strike unexpectedly in children, with severe reactions to certain foods often being life-threatening. Allergy UK says childhood food allergies are becoming increasingly common, with around one in 12 young children affected. It comes as Made In

Why is my hay fever so bad?

A “pollen bomb” over the UK is causing increased misery for hay fever sufferers, with people reporting worse than usual symptoms. The Met Office has warned of very high pollen levels across most of England and

Brace for ‘thunder hay fever’ hell

Millions of hayfever sufferers in Britain were warned today that a high pollen count and thunderstorms will trigger a weather phenomenon known as ‘thunder fever’ as the remnants of a tropical storm lash the country. The