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Posted On: 01/19/2021 7:40:23 PM
Post# of 154140
HGEN
On January 19, 2021, Humanigen, Inc. (the “Company”) provided an update on its ongoing Phase 3 clinical trial of lenzilumab in hospitalized patients with COVID-19. As of January 19, 2021, more than 500 patients have been enrolled in the trial.
In response to the rapidly evolving therapeutic landscape, the primary endpoint of the trial has been changed to ventilator-free survival through day 28, previously one of several secondary endpoints. Time to recovery will be one of several secondary endpoints. The Company believes this change in the primary endpoint represents a more meaningful endpoint for patients, health-care providers, and payors given the current standard of care for hospitalized and hypoxic COVID-19 patients. The protocol and statistical analysis plan for the Phase 3 trial have been updated to reflect these changes. These changes have been reviewed and discussed with FDA and are expected to be posted to clinicaltrials.gov (NCT04351152). The Company remains blinded to the results of this ongoing trial.
On January 19, 2021, Humanigen, Inc. (the “Company”) provided an update on its ongoing Phase 3 clinical trial of lenzilumab in hospitalized patients with COVID-19. As of January 19, 2021, more than 500 patients have been enrolled in the trial.
In response to the rapidly evolving therapeutic landscape, the primary endpoint of the trial has been changed to ventilator-free survival through day 28, previously one of several secondary endpoints. Time to recovery will be one of several secondary endpoints. The Company believes this change in the primary endpoint represents a more meaningful endpoint for patients, health-care providers, and payors given the current standard of care for hospitalized and hypoxic COVID-19 patients. The protocol and statistical analysis plan for the Phase 3 trial have been updated to reflect these changes. These changes have been reviewed and discussed with FDA and are expected to be posted to clinicaltrials.gov (NCT04351152). The Company remains blinded to the results of this ongoing trial.
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