On June 21, 2021 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company on a quest to deliver targeted therapies that treat rare forms of cancer, reported the completion of enrollment for its pivotal Phase 3 MOMENTUM clinical trial evaluating the novel JAK1, JAK2 and ACVR1 / ALK2 inhibitor momelotinib in myelofibrosis patients who are symptomatic and anemic (Press release, Sierra Oncology, JUN 21, 2021, View Source [SID1234584189]). The study enrolled 195 patients based on a planned 180 patients across 21 countries. Topline data are anticipated in Q1 2022, and assuming positive results, the company intends to file a New Drug Application (NDA) with the US Food & Drug Administration (FDA) in H2 2022.
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"This is an important milestone for Sierra on our path to becoming a commercial organization. The team has demonstrated the ability to execute a global late-stage development trial, even during a pandemic," said Stephen Dilly, MBBS, PhD, President and Chief Executive Officer at Sierra Oncology. "Furthermore, oversubscribing the trial and completing enrollment at an accelerated pace in the midst of a global crisis supports our hypothesis that physicians want new options for a significant unmet need that momelotinib may address. We look forward to topline results early next year and to continue working with the FDA and global regulatory authorities to bring this therapy to market as quickly as possible."
About Momelotinib
Momelotinib is a selective and orally bioavailable JAK1, JAK2 and ACVR1 / ALK2 inhibitor for the potential treatment of myelofibrosis. Myelofibrosis results from dysregulated JAK-STAT signaling and is characterized by constitutional symptoms, splenomegaly (enlarged spleen) and progressive anemia.
Momelotinib is currently under investigation in the MOMENTUM clinical trial, a global, randomized, double-blind Phase 3 study for symptomatic and anemic myelofibrosis patients. Top-line data are anticipated in Q1 2022. The U.S. Food & Drug Administration has granted Fast Track designation for momelotinib.