Allergy Tx plots grass pollen jab launch after German okay

UK-listed Allergy Therapeutics has had its grass pollen allergy treatment Grassmuno approved in Germany, its first market, setting up a launch early next year.

Grassmuno – also known as Grass MATA MPL – is also the first subcutaneous grass pollen allergy immunotherapy to be cleared by the Paul Ehrlich Institute (PEI), Germany's medicines regulator, through the TAV (Therapieallergene-Verordnung) framework.

It takes the form of a course of six injections, given before the hayfever season starts, to reduce moderate to severe grass pollen allergy symptoms.

The TAV requires allergy immunotherapies to meet the same regulatory standards as other prescription medicines and undergo a full regulatory review, whereas previously they could be supplied on a named-patient basis.

Older products have been able to be provided under the old framework during a transitional period – while a marketing application is reviewed – but that expires next year, so the approval puts Allergy Therapeutics in a strong market position in Germany, currently its biggest market.

In its annual results statement, published last week, Allergy Therapeutics reported flat revenues of £55 million, which the company said reflected "the earlier than expected impact of the approaching end of the TAV transition period in Germany and the shift to fully licensed products."

According to the company, Grassmuno also has the advantage of being a short course of injections, as other subcutaneous immunotherapy (SCIT) products generally require months-long treatment schedules.

Market research estimates that the seasonal allergy market will grow to a value of around $1 billion by the end of the decade, with grass pollen allergy a "key segment," according to Allergy Therapeutics.

Chief executive Manuel Llobet said the first approval for Grassmuno is a "defining moment" for the AIM-listed company, validates its SCIT platform, and "establishes a strong foundation for our future expansion strategy for this innovative and disruptive immunotherapy with allergens such as birch and ragweed across other major global markets."

Allergy Therapeutics' SCIT platform draws on a proprietary adjuvant (MPL) to boost the tolerance-inducing effects of the injections, assisted by a biodegradable depot technology based on microcrystalline tyrosine (MCT) that also has adjuvant properties.

Grassmuno will be launched in Germany in the first quarter of next year by subsidiary company Bencard Allergie.

The approval of Grassmuno comes on the back of a phase 3 trial, published in the journal Allergy in 2023, which showed a significant reduction in allergy symptom scores using the EAACI-CSMS0–6 scale, compared to placebo, in adults over the peak grass pollen season.

Last year, Allergy Therapeutics started another phase 3 trial to evaluate the short- and long-term efficacy and safety of Grassmuno in children.

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