—Topline data anticipated in Q1 2022 with NDA filing to follow in H2 2022—
SAN MATEO, Calif., June 21, 2021 /PRNewswire/ - Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company on a quest to deliver targeted therapies that treat rare forms of cancer, today announced 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. 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.
"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."
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.
About Sierra Oncology
Sierra Oncology is a late-stage biopharmaceutical company on a quest to deliver targeted therapies that treat rare forms of cancer. We harness our deep scientific expertise to identify compounds that target the root cause of disease to advance targeted therapies with assets on the leading edge of cancer biology. Our team takes an evidence-based approach to understand the limitations of current treatments and explore new ways to change the cancer treatment paradigm. Together we are transforming promise into patient impact.
For more information, visit www.SierraOncology.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Sierra Oncology's expectations regarding the commercialization and future success of momelotinib and future expansion of its pipeline. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, including, among others, the risk that Sierra Oncology's cash resources may be insufficient to fund its current operating plans and it may be unable to raise additional capital when needed, the risk that disruptions and impacts of COVID-19 will be significant and lengthy, Sierra Oncology may be unable to successfully develop and commercialize momelotinib, momelotinib may not demonstrate safety and efficacy or otherwise produce positive results, Sierra Oncology may experience delays in the clinical development of momelotinib, Sierra Oncology may be unable to acquire additional assets to build a pipeline of additional product candidates, Sierra Oncology's third-party manufacturers may cause its supply of materials to become limited or interrupted or fail to be of satisfactory quantity or quality, Sierra Oncology may be unable to obtain and enforce intellectual property protection for its technologies and momelotinib and the other factors described under the heading "Risk Factors" set forth in Sierra Oncology's filings with the Securities and Exchange Commission from time to time. Sierra Oncology undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.
SOURCE Sierra Oncology