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Novartis downplays late-stage asthma drug failures

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Novartis’ experimental asthma treatment fevipiprant failed to improve lung function in a pair of Phase 3 studies of patients with moderate asthma, the Swiss pharma disclosed Tuesday in its third quarter earnings report. Company executives downplayed the clinical failures, positioning two other late-stage asthma trials set to read out in the first quarter of 2020 as the critical ones. Those studies are in moderate to severe asthma and will test for reductions in flare-ups after a year instead of changes to a breathing test score after 12 weeks.The study failures were a blemish on an otherwise successful quarter for Novartis, which included a strong commercial start for its gene therapy Zolgensma. The company raised its sales expectations for 2019, as the first nine months of the year have brought in $35 billion, up 5% from a year ago.

Fevipiprant leads the experimental therapeutic class of DP2 antagonists and is being tested in two pairs of Phase 3 asthma tests, called ZEAL and LUSTER.

The first pair, disclosed Tuesday and called ZEAL 1 and ZEAL 2, failed to improve how much air a person can exhale during the first second of a forced breath, known as FEV1, among moderate asthmatic patients.

The DP2 therapeutic class also includes the leading drug candidate for Gossamer Bio, a biotech that went public earlier this year.

Gossamer’s lead therapy, GB001, is in Phase 2b testing for moderate to severe eosinophilic asthma, leading investors to watch Novartis for potential readthroughs to Gossamer’s probability at success. Shares swung wildly Tuesday morning, with the biotech dropping more than 30% in pre-market trading before rebounding to be up 5% by midday.

Novartis’ explanation helps explain that movement. On a Tuesday morning call with analysts, Novartis’ chief medical officer and global head of drug development John Tsai reaffirmed optimism that the coming readouts for LUSTER 1 and LUSTER 2 will fare better. Those trials more closely match the patient population GB001 is testing.

The LUSTER trials are testing a reduction in exacerbations among more severe cases of asthma than ZEAL, which Tsai expects should bring better clinical results.

“What we know is that DP2 activation increases with disease,” Tsai said. “So, in fact, as you have more disease, you would likely get more response from DP2s.”

Novartis execs have seen topline results from the LUSTER 2 study, which has already been completed, company CEO Vas Narasimhan said.

“We do have the initial readout from that study, but we are awaiting the LUSTER 1 readout to understand where the overall program and the pooled analysis sits, all the elements that would be required for a regulatory filing,” he added.

The Swiss pharma reiterated its plan to file a New Drug Application for fevipiprant in 2020, and that led Wall Street analysts to interpret the drug as likely to bring success in the LUSTER trials.

“This filing reaffirmation and nod to a peek at early exacerbation data suggests to us that despite the ZEAL miss, [Novartis] remains confident and dedicated to fevipiprant development to address moderate-to-severe asthma [patients],” SVB Leerink analyst Joseph Schwartz wrote Tuesday.

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