Novartis provides update on LUSTER Phase III studies in patients with uncontrolled GINA 4/5 asthma
Novartis recently announced topline results from its pivotal global Phase III LUSTER-11 and LUSTER-22 studies that explored the efficacy and safety of the investigational oral, once-daily, DP2 receptor antagonist fevipiprant (QAW039). The pooled analysis showed that during the 52-week treatment period, the two doses of fevipiprant (150mg / 450mg) did not reach the clinically relevant threshold for reducing the rate of moderate to severe deterioration compared to placebo.These studies included patients with moderate to severe asthma who were not adequately controlled despite receiving inhaled medium-to-high-dose corticosteroids (ICS) and at least one additional control drug (GINA grade 4 or 5).
Fevipiprant is an investigational, novel, steroid-free once-daily pill. It blocks the DP2 pathway, a potentially important regulator of the asthma inflammatory cascade.Novartis said that the overall results from the above two studies do not support the further clinical development of fevipiprant in the treatment of asthma.In these studies, Fevipiprant was generally well tolerated, with treatment-emergent adverse events generally balanced across groups and comparable to placebo.Novartis is currently analyzing detailed efficacy and safety data for the LUSTER-1 and LUSTER-2 studies.