Gossamer Bio Inc. (NASDAQ: GOSS) shares dived on Tuesday after the company announced midstage results from its asthma and chronic rhinosinusitis studies. Specifically, the results are coming from the Phase 2b LEDA trial in patients with moderate-to-severe eosinophilic asthma and its Phase 2 TITAN trial in patients with chronic rhinosinusitis.
While statistical significance on the primary endpoint in the LEDA study was not achieved, management said that it was encouraged by the consistent results observed for all three doses across the primary and secondary endpoints.
The primary endpoint, asthma worsening, included five components and was chosen for its sensitivity in detecting deterioration in clinical outcome measures known to be correlated with exacerbations. Basically, asthma was considered to have worsened it it hit any of the five components. In a sense this was a way to falsify results, where hitting any of these components is not a positive result for the study. This endpoint previously has been used in the context of steroid withdrawal studies, including a prior Phase 2 trial of GB001.
Again, the primary endpoint of the trial was not met, but consistent and meaningful numeric reductions in the odds of asthma worsening as compared to placebo were observed across all GB001 groups. Additionally, statistically significant improvements in the key secondary endpoint of time to first asthma worsening as compared to placebo were observed for GB001.
Looking ahead, management believes these data provide important information for designing a well-powered Phase 3 program for GB001 in severe asthma. The firm plans to engage in global regulatory discussions in order to inform its thinking around potential partnerships or strategic alternatives for this program.
The proof-of-concept TITAN trial enrolled 97 patients with chronic rhinosinusitis, with and without nasal polyp, and assessed treatment with GB001 versus the placebo over 16 weeks. Neither the primary nor the secondary endpoints of the trial were met. The company does not plan on further developing GB001 in chronic rhinosinusitis.
Gossamer stock traded down about 34% to $8.98 on Tuesday, in a 52-week range of $7.52 to $27.15. The consensus price target is $28.63.
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