Novartis dumps asthma program after another set of phase 3 flops

Novartis headquarters
Novartis retains an interest in DP2, noting the educational value of the recent phase 3 flops. (Novartis)

Novartis’ fevipiprant has failed another pair of phase 3 clinical trials, prompting the Swiss pharma to halt further development of the DP2 antagonist in asthma. The setback means Amgen, AstraZeneca and Novartis have now targeted DP2 without success, raising doubts about whether Gossamer Bio will fare better when it delivers data next year.

In October, Novartis revealed fevipiprant had failed to improve lung function, as measured by FEV1, over placebo in two phase 3 trials that enrolled patients with moderate, uncontrolled asthma. The blow left Novartis looking to a pair of trials in moderate-to-severe asthma exacerbations for results to support approval of the drug, which some analysts have tipped as a blockbuster.

Now, Novartis has shared top-line data from the two asthma exacerbation trials. Pooled analyses of the data showed neither dose of fevipiprant met “the clinically relevant threshold for reduction in rate of moderate-to-severe exacerbation compared to placebo over a 52-week treatment period.” 

Novartis will share the numbers from the study at an upcoming medical congress. Whatever the trial found was bad enough for Novartis to kill fevipiprant in asthma on the grounds that “the totality of these results do not support further development.”

That conclusion is the latest in a series of blows for the hypothesis that DP2 antagonism can improve outcomes in asthma. DP2 is a receptor involved in inflammatory processes behind allergic asthma, a function that raised hopes a new class of drugs against the target could help the large numbers of patients whose conditions are poorly controlled by current treatment options. Those hopes have been hurt by clinical failures at Amgen, AstraZeneca and now Novartis.

Gossamer may deal a further blow to the DP2 hypothesis when it shares an interim analysis from a phase 2b trial next year. The potential of Gossamer’s DP2 drug, GB001, led investors to power the biotech to a $276 million IPO. Shares in Gossamer have risen around 50% since Novartis shared data on its first set of phase 3 fevipiprant flops, but fell more than 30% in early trading Monday morning on the news.

On the flipside, if Gossamer can guide GB001 to market, it will not face competition from fevipiprant in asthma. Novartis still retains an interest in DP2, though, noting the educational value of the phase 3 flops.  

“While the results of the LUSTER studies with fevipiprant are disappointing, they meaningfully contribute to our understanding of the DP2 pathway in asthma,” John Tsai, head of global drug development and chief medical officer at Novartis, said in a statement.