GOSS - Gossamer Bio's GB001 flunks both asthma and rhinosinusitis studies

Gossamer Bio (GOSS) announced that two studies in GB001, Phase 2B LEDA trial in eosinophilic asthma and Phase 2 TITAN trial in chronic rhinosinusitis, failed to meet the primary endpoints.The 480-subject LEDA study did not meet the primary endpoint of asthma worsening. Though the company says that consistent and meaningful numeric reductions in the odds of asthma worsening as compared to placebo were observed: 33% (p=0.1425), 32% (p=0.1482), and 35% (p=0.1086), for GB001 20 mg, 40 mg, and 60 mg groups, respectively.Statistically significant improvements in key secondary endpoint of time to first asthma worsening of 28% and 30% observed for 20 mg and 60 mg doses of GB001, respectively; 23% improvement observed in 40 mg group.On the safety front, incidence of adverse events was generally comparable across treatment groups.Adverse events of interest (liver chemistry elevations leading to study drug discontinuation) occurred more frequently in GB001 60 mg (4.1%, n=5) than placebo (0.8%, n=1), GB001

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Gossamer Bio's GB001 flunks both asthma and rhinosinusitis studies