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Novartis to shelve late-stage oral asthma hope fevipiprant after trial failure

Novartis AG will end its development of a once-a-day pill for asthma after it failed two late-stage studies in moderate to severe forms of the disorder.

The Basel, Switzerland-based pharmaceutical group announced that fevipiprant did not meet the threshold of cutting moderate to severe asthma exacerbations compared with placebo in the Luster-1 and Luster-2 studies over a 52-week period, at either the high dose or the low dose. The results are consistent with data from the ZEAL-1 and ZEAL-2 studies released Oct. 22, in which fevipiprant failed to show efficacy in a milder version of the disease.

Fevipiprant is an experimental, steroid-free once-daily pill, which works by blocking the DP2 pathway, a potentially important regulator of the asthma inflammatory cascade. The late-stage compound was part of a stable of offerings, recently highlighted at the R&D update, that analysts had been watching closely as potential drivers of Novartis' next wave of growth. Deutsche Bank analyst Richard Parkes had previously considered it a potential multi-blockbuster, should it have been able to replicate the same clinical benefits as the new injectable biologic therapies for severe asthma.

"Lack of true proof-of-concept and lackluster data with other drugs in its class, along with recent failure of the ZEAL Phase III trials in moderate asthma patients have left most investors and analysts skeptical," Parkes wrote in a Dec. 9 research note. Ahead of the Luster results, Wolfe Pharma analyst Tim Anderson also had only penciled in odds of 50/50 for the research program and did not have revenue forecasts in his model. Consensus analyst expectations were for 2027 sales of $900 million, according to Anderson.

Fevipiprant was hoping to fill the gap between the use of inhalers for asthma — a chronic disease that affects some 235 million people globally, according to the World Health Organization and biologics. Biologics have demonstrated stronger efficacy in patients with severe asthma and companies including Sanofi, GlaxoSmithKline PLC and AstraZeneca PLC are investing in protein-based medicines to address serious lung conditions.

Novartis said it has a number of other late-stage products, including two in phase 3 for moderate to severe asthma, QVM149 and QMF149, and others for chronic obstructive pulmonary disorder, as well as for idiopathic pulmonary fibrosis and sarcoidosis.

"While the results of the Luster studies with fevipiprant are disappointing, they meaningfully contribute to our understanding of the DP2 pathway in asthma," said John Tsai, Novartis' head of global drug development and chief medical officer.

Novartis shares were little changed at 91.25 Swiss francs by 3:21 p.m. Basel time.