Novartis axes asthma drug fevipiprant after more trial woes

It’s nearly always bad news when pharma companies provide an “update” about a trial – and the statement today from Novartis about its asthma drug fevipiprant must make bleak reading for all those involved in its development.

The Swiss firm has abandoned development of fevipiprant in asthma after another double phase 3 trial failure.

Novartis has been active in respiratory diseases, with its Xolair asthma drug figuring among the big pharma’s top 20 drugs.

While Xolair is something of an also-ran in terms of sales at around $300 million per quarter Novartis had been hoping that fevipiprant would prove to be a game-changer in some forms of asthma and generate blockbuster-level revenues in the process.

But it wasn’t to be: a pooled analysis of the LUSTER-1 and LUSTER-2 studies exploring efficacy of the DP2 receptor antagonist in moderate-to-severe disease showed the drug was no better than placebo at reducing asthma exacerbations at either 150 mg or 450 mg doses.

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.

Novartis said that the “totality of these results do not support further development of fevipiprant in asthma.”

Fevipiprant was generally well tolerated, with treatment-emergent adverse events generally balanced across groups and comparable to placebo.

The decision to axe fevipiprant was not a huge surprise as the drug was already considered to be on life support by analysts after failure of two other trials, ZEAL 1 and ZEAL 2, in October.

Those trials were studying whether the drug improved forced expiratory lung volume in one minute – another benchmark that crops up in asthma trials.

The news from Novartis was also bad for its rival Gossamer Bio, which is also developing a DP2 class asthma drug.

Shares in the San Diego-based biotech ticked down following the announcement, although most of the damage has already been done to its value after a huge fall following the ZEAL announcements in October.

Detailed efficacy and safety data from the LUSTER-1 and LUSTER-2 studies are being analysed and will be submitted for presentation at an upcoming medical congress, Novartis added.

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