Novartis announced that its asthma treatment fevipiprant has failed to meet the clinically relevant threshold in Luster phase III studies.
The company has unveiled the topline results from its global phase 111 Luster-1 and Luster-2 studies evaluating the efficacy and safety of the investigational oral, once-daily, DP2 receptor antagonist fevipiprant.
Fevipiprant, an investigational, novel and steroid-free once-daily pill, inhibits the DP2 pathway, which is a significant regulator of the asthma inflammatory cascade.
The pooled analyses of the studies failed to meet the clinically relevant threshold for the reduction in the rate of moderate-to-severe exacerbation compared to placebo over a 52-week treatment period for either of the doses (150mg / 450mg).
The trials included patients who had inadequately controlled moderate-to-severe asthma although securing inhaled mid-to-high dose corticosteroids (ICS) and at least one additional controller.
According to the company, the totality of the results does not support further development of fevipiprant in asthma.
Novartis has also announced that it will analyse the efficacy and safety data from both studies in detail and will submit for presentation at an upcoming medical congress.
The Luster-1 and Luster-2 trials are part of the Vibrant phase III programme that is also comprised of the SPIRIT safety study and the supplemental replicate Zeal-1 and Zeal-2 studies.
Both studies were 52-week, randomised, multi-centre, double-blind, placebo-controlled and replicate phase III trials in patients with moderate-severe asthma.
Novartis recruited 894 patients in Luster-1 trial and 877 patients in Luster-2 trial. The patients have aged above or equal to 12 years.
Novartis chief medical officer and global drug development head John Tsai said: “While the results of the LUSTER studies with fevipiprant are disappointing, they meaningfully contribute to our understanding of the DP2 pathway in asthma.
“We are incredibly grateful to all the patients, their families and the investigators who participated in the studies and contributed greatly to this research.”
Novartis’ respiratory medicine portfolio is comprised of Xolair for severe allergic asthma and chronic spontaneous urticarial, Ultibro Breezhaler for COPD and the phase III investigational products for moderate-to-severe asthma.
In November, Novartis’ EXCEED phase 3b trial, which has been evaluating Cosentyx (secukinumab) in active psoriatic arthritis (PsA) in comparison to Humira (adalimumab), has yielded mixed results.