Amgen and AstraZeneca report positive results of Phase IIb asthma trial
Amgen and AstraZeneca have reported positive results from a Phase IIb clinical trial (PATHWAY) of tezepelumab to treat patients with severe uncontrolled asthma.
tezepelumab is an anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody currently being developed by AstraZeneca's global biologics research and development arm MedImmune in alliance with Amgen.
The trial has met the primary efficacy endpoint with significant decrease in the annual asthma exacerbation rate when compared to placebo.
Rate reduction of 61% was observed with 70mg of tezepelumab, while 71% was discovered with 210mg and 66% with 280mg.
The randomised, double-blind, parallel group, placebo-controlled PATHWAY trial assessed the efficacy and safety of every four week doses of 70mg and 210mg, and every two week doses of 280mg.
Tezepelumab was administered as an add-on therapy to patients who had a history of asthma exacerbations and were receiving inhaled corticosteroids / long-acting beta-agonists with or without oral corticosteroids and additional asthma controllers.
Amgen research and development executive vice-president Sean Harper said: "The responses seen with tezepelumab in the PATHWAY trial show promise for a novel therapeutic option with the potential to impact multiple downstream inflammatory pathways associated with asthma.
"We are committed to leveraging our deep understanding of inflammatory pathways to develop innovative treatments that address significant unmet medical needs."
The results also indicated lung function improvements at all doses and in asthma control at 210mg and 280mg doses of tezepelumab.
It was observed that the incidence of adverse events was similar for tezepelumab and placebo, with asthma, nasopharyngitis, headaches and bronchitis being the most common events in case of patients treated with tezepelumab.
Image: Illustration of lungs affected with asthma. Photo: courtesy of BruceBlaus.