Astrazeneca, Amgen Phase IIb Trial Of Tezepelumab Met Primary Endpoint

AstraZeneca (AZN) and Amgen (AMGN) announced results from the Pathway Phase IIb trial of tezepelumab that they say “showed a significant reduction” in the annual asthma exacerbation rate compared with placebo in patients with severe, uncontrolled asthma. Tezepelumab is a first-in-class anti-TSLP monoclonal antibody being developed by AstraZeneca’s ‘s MedImmune, in collaboration with Amgen.

The trial results were published today in the New England Journal of Medicine, and will be followed by an oral presentation on September 12 at the ERS International Congress 2017 in Milan. The Pathway trial achieved its primary efficacy endpoint, showing annual asthma exacerbation rate reductions of 61%, 71% and 66% in the tezepelumab arms receiving either 70mg or 210mg every four weeks or 280mg every two weeks, respectively. In the trial, tezepelumab was given as an add-on therapy to patients with a history of asthma exacerbations and uncontrolled asthma despite receiving inhaled corticosteroids/long-acting beta-agonists with or without oral corticosteroids and additional asthma controllers. Significant and clinically-meaningful reductions in the exacerbation rate were observed independent of baseline blood eosinophil count or other type 2 inflammatory biomarkers, the companies announced.