Two Trial Halts In A Row - Gilead Sciences Stops Late Stage COVID-19 Study

Gilead Sciences Inc GILD said it has stopped patient enrollment in BIRCH (Study GS-US-611-6273), a Phase 3 study evaluating the efficacy and safety of obeldesivir compared with placebo in non-hospitalized participants who are at high risk for developing severe COVID-19. 

This decision is based on lower-than-expected COVID-19 incidence rates and related hospitalizations or all-cause death by Day 29, which are primary endpoints in the study. Patients already enrolled will continue in the study, which remains blinded.

The decision to stop enrolling patients in the BIRCH study does not impact the OAKTREE study (GS-US-611-6549), a Phase 3 study evaluating the safety and efficacy of obeldesivir compared with placebo in non-hospitalized participants without risk factors for developing severe COVID-19. 

Tuesday, Gilead stopped its ENHANCE-2 study in acute myeloid leukemia (AML) with TP53 mutations, evaluating magrolimab plus azacitidine. 

Also Read: FDA Pauses Gilead's Investigational Magrolimab Study In Blood Cancer Patients.

Based on an ad hoc analysis and following review by an independent data monitoring committee, Gilead concluded that magrolimab is unlikely to demonstrate a survival benefit compared to the standard of care. 

No new safety signals were identified, and the safety profile was comparable between treatment arms. 

Price Action: GILD shares are down 0.05% at $75.51 on the last check Thursday.