Stallergenes' allergy immunotherapy hits goal in phase 3

House dust mites
House dust mites. (Wikimedia Commons)

A phase 3 trial of Stallergenes Greer’s treatment for house dust mite (HDM)-induced allergic rhinitis has met its primary endpoint. The late-phase success sets Stallergenes up to file for FDA approval of oral immunotherapy STAGR320.

Investigators enrolled 1,600 patients in the clinical trial and randomized them to receive daily doses of STAGR320 or placebo for 12 months. Stallergenes hoped the patients who took its immunotherapy would experience symptom relief and require less rescue medication, outcomes it packaged up into a combined primary endpoint.

The trial met that endpoint with a p value of less than 0.0001. With the study also hitting key secondary endpoints and validating the safety of STAGR320, Stallergenes thinks it has the data to support a BLA filing to the FDA.

STAGR320 is already registered in Australia, Japan, New Zealand and South Korea but Stallergenes needed more data to access other countries and increase penetration in existing markets. In addition to the BLA filing, Stallergenes is preparing to seek additional marketing authorizations in Europe and other markets. The data could also help to win over doctors who already have access to the drug.

“These study results provide the physician community with compelling evidence that STAGR320 can address some of the most severe symptoms that patients experience, which ultimately has an impact on quality of life,” Pascal Demoly, a coordinating investigator on the phase 3, said in a statement.

The market for STAGR320 could be sizable. A European study found HDM is the most common inhalant allergy, and the consequences for sufferers can be significant. The resulting allergic rhinitis is detrimental to quality of life and puts patients at a raised risk of asthma.

In recent years, ALK and Stallergenes have independently sought to provide sufferers with an oral treatment. ALK won FDA approval for its HDM sublingual allergy immunotherapy tablet last year.

Shares in Stallergenes rose 9% following news of the data.