Gossamer loses its Luster on fevipiprant flop

Novartis’s DP2 inhibitor fevipiprant had always looked like a long shot in asthma. After the company snuck news of the failure of the project’s first pivotal trials into its third-quarter earnings today, the main question now is what it means for Gossamer Bio’s lead asset, GB001, which also hits DP2. Investors are not holding out much hope: Gossamer's stock plunged 36% in premarket trading today. Novartis isn’t saying much about the Zeal 1 and 2 studies, except that they did not meet their primary endpoint of improved forced expiratory volume in one second (FEV1). The Swiss group has more chances in Luster 1 and 2, which are due to report in the first quarter of next year, and the company is now calling these its “core registrational trials”. Novartis will have to hope that a sicker patient population and a different primary endpoint, exacerbations, will help Luster succeed where Zeal failed. So will Gossamer. The smaller group has been trying to play down the importance of FEV1, and the company’s sellside cheerleaders have long maintained that the Luster studies, and particularly the results in patients with high eosinophils, will provide a better read-across to GB001’s potential.

Upcoming readouts with DP2 inhibitors
Project Company Trial name Indication Primary endpoint Data due 2024e sales ($m)
Fevipiprant/ QAW039 Novartis Zeal 1 Moderate uncontrolled asthma (Gina 3/4) FEV1 at 12 weeks Failed 619
Zeal 2 Moderate uncontrolled asthma (Gina 3/4) FEV1 at 12 weeks Failed
Luster 1 Moderate-to-severe uncontrolled asthma (Gina 4/5) Exacerbations at one year Q1 2020
Luster 2 Moderate-to-severe uncontrolled asthma (Gina 4/5) Exacerbations at one year Q1 2020
GB001 Gossamer Bio Leda (phII) Moderate-to-severe eosinophilic asthma (Gina 4/5) Asthma worsening composite at 24 weeks 2020 272
Gina: Global Initiative on Asthma; Source: EvaluatePharma, clinicaltrials.gov.

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