Novartis Announces Phase 3 Clinical Failure of Asthma Drug Fevipiprant

Compiled by Fan Dongdong

Recently, Novartis announced that its asthma reliever fevipiprant failed to improve patients' lung function compared with placebo in two Phase 3 clinical trials (ZEAL 1 and ZEAL 2). Novartis did not disclose whether the drug met secondary endpoints in the trials, including metrics such as daytime asthma symptom scores and quality of life.

It is understood that each of the two studies enrolled approximately 700 patients with asthma whose condition was not effectively controlled, and randomly assigned them to receive once-daily fevipiprant or placebo in addition to standard therapy. The primary endpoint was the change in forced expiratory volume in one second (FEV1) after 12 weeks.

In fact, when the Phase 2b clinical trial results of fevipiprant were announced, although fevipiprant improved FEV1 levels in asthma patients, details of the data (such as the lack of a dose-response relationship) raised skepticism about its Phase 3 clinical trials. At that time, Jefferies analysts believed that the probability of success for Fevipiprant’s Phase 3 clinical trials was only 30%.

Nevertheless, Novartis remains optimistic about the drug, stating that it will continue to conduct the other two Phase 3 trials of fevipiprant (LUSTER-1 and LUSTER-2) to evaluate the efficacy of fevipiprant in reducing acute exacerbations in patients with moderate-to-severe asthma. These late-stage asthma trials are pivotal, with results expected to be released in the first quarter of 2020. Furthermore, Novartis reiterated its plan to submit a New Drug Application for fevipiprant in 2020.

Fevipiprant Molecular Structural Formula

Fevipiprant is a DP2 antagonist. DP2 is a receptor involved in driving the inflammatory process of allergic asthma, leading researchers to identify this target as the foundation for developing novel asthma therapies capable of treating a small subset of patients with uncontrolled asthma. However, the development of such drugs has faced challenges; DP2-targeting agents developed by AstraZeneca and Amgen have also failed in clinical trials.

DP2 therapeutic agents also include the lead candidate from biotech company Gossamer Bio, which went public earlier this year. Gossamer’s primary therapy, GB001, is currently in Phase 2b clinical trials for moderate-to-severe eosinophilic asthma. The failure of Novartis’ trial has led investors to reassess the potential success rate of GB001, causing its stock price to plummet on the day.

References:

1、Novartis' asthma drug fails in phase 3, raising doubts about Gossamer's prospects

2、Novartis downplays late-stage asthma drug failures