Swiss pharma giant Novartis (NOVN: VX) today announced further disappointing news for its asthma candidate, with top-line results from its pivotal global Phase III LUSTER-1 and LUSTER-2 studies exploring the efficacy and safety of the investigational oral, once-daily, DP2 receptor antagonist fevipiprant (QAW039).
The pooled analyses of the LUSTER trials did not meet the clinically-relevant threshold for reduction in rate of moderate -to-severe exacerbation compared to placebo over a 52-week treatment period for either of the doses (150mg / 450 mg). The studies included patients who had inadequately controlled moderate-to-severe asthma (GINA Steps 4 and 5) despite receiving inhaled mid-to-high dose corticosteroids (ICS) and at least one additional controller.
In October this year, Novartis released top-line data for fevipiprant showing the drug failed to improve lung function in two late-stage studies.
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