Gilead Sciences, Inc. (NASDAQ:GILD) started on the back foot on Monday after the biopharmaceutical company told investors it has discontinued its Phase 3 ENHANCE study of its investigational anti-CD47 antibody magrolimab for the treatment of patients with higher-risk myelodysplastic syndromes (HR-MDS).
Foster City, California-based Gilead said in a statement the decision to end the study was due to “futility based on a planned analysis.”
The safety data seen in the study was consistent with the known magrolimab profile and adverse events that were typical in this patient population, Gilead said, adding that it recommends discontinuing treatment with magrolimab in patients with MDS.
Magrolimab is a potential first-in-class, anti-CD47 immunotherapy with a clinical development program spanning 10 potential indications including ongoing trials in solid tumors and two pivotal trials.
“The health and well-being of patients are our top priorities and while this is disappointing news it confirms the challenges of treating HR-MDS, where no new class of treatments have been approved in nearly 20 years,” Gilead Sciences chief medical officer said Merdad Parsey said.
“Gilead is deeply grateful to the patients, families, investigators, and the advocacy community who contributed to this research as we learn more about magrolimab and explore its potential in treating other cancers.”
The company said it is working with study investigators on appropriate next steps for patients enrolled in the ENHANCE study. Data will be submitted for presentation at an upcoming medical meeting, it added.
Gilead’s shares were down 1.7% at $79.25 in early trade.
Contact the author at stephen.gunnion@proactiveinvestors.com