Exhibit 99.1
Sierra Announces FDA Regulatory Clarity for Momelotinib & Design of the MOMENTUM Phase 3 Clinical Trial
- MOMENTUM Phase 3 clinical trial planned for launch in Q4 2019; topline efficacy data anticipated in Q4 2021 –
- World renowned myelofibrosis expert Dr. Srdan Verstovsek named Chief Investigator of the MOMENTUM Phase 3 study -
- 180 patient 2:1 randomized, double blind clinical trial design versus danazol -
- Study powered 99% on primary endpoint of symptomatic benefit; >90% powered on secondary endpoints of anemia benefit and spleen reduction -
- Sierra hosting Analyst and Investor call at 6:00am ET on Wednesday, June 5, 2019 -
VANCOUVER, June 4, 2019 - Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, today announced that it has obtained regulatory clarity with the U.S. Food and Drug Administration (FDA) concerning the design of a Phase 3 clinical trial for momelotinib intended to support potential registration of this differentiated drug candidate for the treatment of previously JAK inhibitor treated myelofibrosis patients. Following receipt of this clarity, Sierra also announced the design of the MOMENTUM Phase 3 clinical trial in myelofibrosis, planned for launch in Q4 2019.
“We have held productive discussions with regulators in the US and EU, presenting a holistic analysis of momelotinib’s compelling array of positive efficacy and safety data observed in the two previously completed SIMPLIFY Phase 3 clinical studies, along with our strategy to conduct an additional Phase 3 trial intended to support momelotinib’s potential registration,” said Dr. Nick Glover, President and CEO of Sierra Oncology. “We have been exceedingly pleased with the collaborative nature of these discussions which have culminated in alignment on the path to potential registration for momelotinib. Moreover, we have received constructive input that ensures that the design of the MOMENTUM Phase 3 study has the potential to generate compelling and persuasive clinical data capable of satisfying regulatory requirements.”
“Momelotinib has consistently demonstrated clinically relevant benefits on the three hallmarks of myelofibrosis: symptoms, anemia and spleen enlargement,” noted Dr. Srdan Verstovsek, MD, PhD, Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, Houston, Texas. “I have been involved in the development of momelotinib for many years, and I am very pleased to be named Chief Investigator of the MOMENTUM Phase 3 study. In my opinion, a good proportion of myelofibrosis patients in the second line setting would be candidates for momelotinib treatment due to its potential ability to improve both quality of life and anemia in a significant number of patients. As a myelofibrosis clinician, I can attest that we desperately need more treatment options that offer an array of distinct benefits for our patients. I look forward to momelotinib potentially becoming an important addition to the armamentarium in the treatment of myelofibrosis.”
“We have designed MOMENTUM in order to generate highly persuasive clinical data with the potential to convincingly demonstrate momelotinib’s meaningful benefits on symptoms, anemia and spleen in the population of patients previously treated with a JAK inhibitor, as supplemented by bothtop-line and post hoc analyses of the prior SIMPLIFY Phase 3 datasets,” said Dr. Barbara Klencke, Chief Development Officer, of Sierra Oncology. “We have outlined a robust, tractable study that we plan to launch in Q4 2019 and that we anticipate will yieldtop-line clinical data in Q4 2021.”
