Stallergenes Greer's dust mite allergy drug clears pivotal study, edges closer to approval
In a bid to tackle one of the most common allergens that asthma patients are sensitive to, Stallergenes Greer’s house dust mite immunotherapy is one step closer to winning approval after reporting successful late-stage data on Tuesday.
The London-based allergy biotech said its sublingual tablet STAGR320 provoked a statistically significant reduction in house dust mite(HDM)-induced allergic rhinitis symptoms (p<0.0001) against a placebo, meeting the main goal of the study.
Data from the trial of 1,600 patients aged 12-65 that had suffered symptoms for at least one year are compelling enough for regulatory submissions in the United States and Europe, the company said. The earliest the drug could hit the market in either geography is 2020, chief Fereydoun Firouz told Endpoints News.
House dust mites, which are too minuscule to be detected by the naked eye, are close relatives of ticks and spiders and gorge on skin shed by humans. An average adult human may shed up to 1.5 grams of skin in a day — enough to feed one million dust mites, according to the Asthma and Allergy Foundation of America, which estimates HDM-induced allergies affect some 20 million Americans.
Right now, many patients who suffer from HDM-induced allergic rhinitis go untreated or take medications such as antihistamines that only treat the symptoms of the allergy, unlike STAGR320, which addresses the underlying cause of the disease and can provide long-lasting reduction of allergy symptoms, said Firouz, noting that most patients seek relief through symptomatic medications and only roughly 10% of patients with allergic rhinitis are treated with allergy immunotherapy.
Allergic rhinitis affects more than half a billion people globally, and more than one-third of those are affected as a result of an allergy to house dust mites, added Firouz. The risk of developing asthma is about six times higher in patients with an allergy to house dust mites than those allergic to pollens, according to Stallergenes Greer.
The immunotherapy, if approved, will likely compete with Merck’s $MRK Odactra, which was given the FDA nod last year as an alternative to allergy shots administered to manage symptoms. However, Odactra’s approval only covers adults, while STAGR320 could potentially win approval for use in adolescents in addition to adults. In Europe, STAGR320 will potentially be stacked up against ALK’s Acarizax.