Merck has launched Shorespan-007, a Phase 3 clinical trial evaluating bomedemstat for treating patients with essential thrombocythemia (ET) who haven’t received cytoreductive therapy.
Essential thrombocythemia, a chronic rare blood disorder, is the most common myeloproliferative neoplasm. The standard of care hasn’t changed significantly in decades, leaving patients needing new options for disease control and improved quality of life.
Shorespan-007 is a randomized, double-blind, active comparator-controlled clinical trial comparing bomedemstat to the standard chemotherapy hydroxyurea in approximately 300 patients with ET. Its primary endpoint is a durable clinicohematologic response rate. Key secondary endpoints include fatigue symptom score, PROMIS Fatigue SF-7a total fatigue score, and MFSAF v4.0 total symptom score.
Bomedemstat is also being investigated in Shorespan-006, a Phase 3 trial comparing it to the best available therapy in patients with ET who have an inadequate response to or are intolerant of hydroxyurea.
Bomedemstat has received FDA Orphan Drug and Fast Track Designations for the treatment of ET and myelofibrosis, an Orphan Drug Designation for the treatment of acute myeloid leukemia, and a Priority Medicines scheme designation by the European Medicines Agency for the treatment of myelofibrosis.
Updated Phase 2b Shorespan-003 trial data, including first-time genomic data, were presented at the American Society of Hematology Annual Meeting in December 2023.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
