Late-stage drug development company Sierra Oncology (SRRA:NASDAQ), which is focused on delivering targeted therapies for hematological disorders and rare cancers, today announced "positive topline data from the pivotal Phase 3 MOMENTUM study—a global, randomized, double-blind clinical trial evaluating momelotinib (MMB) in myelofibrosis patients who are symptomatic and anemic and previously treated with an approved JAK inhibitor."
The company advised that in the MOMENTUM trial, MMB successful met all primary and key secondary endpoints.
The company's President and CEO Stephen Dilly, MBBS, Ph.D. stated, "These data are extremely exciting and everything we had hoped to see from the trial…To achieve statistically significant and clinically important efficacy across all prespecified primary and key secondary endpoints while maintaining platelet counts in such a difficult to treat patient population is remarkable, and a confirmation of the anemia response we identified in the comprehensive review of our previous Phase 3 studies."
Ruben Mesa, M.D., FACP, Executive Director of the Mays Cancer Center, home to UT Health San Antonio, MD Anderson Cancer Center, and co-Principal Investigator of the study remarked, "As a clinician, I am thrilled to see data that confirm the potential of momelotinib as a treatment option for myelofibrosis patients who are anemic or at risk of becoming anemic…Anemia of myelofibrosis is strongly correlated with reduced quality of life and a decrease in overall survival."
"With currently approved therapies being myelosuppressive, it's wonderful to know that we may soon have such an effective treatment option for these patients," Dr. Mesa added.
Sierra Oncology's Chief Medical Officer Barbara Klencke, M.D., commented "We are committed to working tirelessly to bring momelotinib to patients as quickly as possible. We would like to thank the patients and investigators who participated in this study and look forward to presenting the full data set at an upcoming medical meeting."
The company listed that Momelotinib is a "potent, selective and orally bioavailable JAK1, JAK2 and ACVR1 / ALK2 inhibitor under investigation for the treatment of myelofibrosis in symptomatic, anemic patients previously treated with an approved JAK inhibitor." The firm said that since the first clinical studies were initiated in 2009, over 1,200 patient subjects have been administered momelotinib with the vast majority of those being treated specifically for myelofibrosis. According to the company, "momelotinib is the first and only JAK inhibitor to demonstrate positive data for all key hallmarks of the disease—symptoms, splenic response and anemia."
The firm defined myelofibrosis as "a rare blood cancer that results from dysregulated JAK-STAT signaling characterized by constitutional symptoms, splenomegaly (enlarged spleen) and progressive anemia."
The company explained that the Phase 3 MOMENTUM trial was a randomized, double-blind clinical study comparing momelotinib versus danazol in symptomatic and anemic myelofibrosis patients who had received prior treatment of an FDA-approved JAK inhibitor. The firm advised that Danazol was chosen as a comparator treatment due to its accepted use in ameliorating anemia in patients experiencing myelofibrosis. To date, the study has enrolled 195 participants in twenty-one countries.
The firm stated that the study was specifically organized to "evaluate the safety and efficacy of momelotinib for the treatment and reduction of the key hallmarks of disease: symptoms, blood transfusions (due to anemia) and splenomegaly (enlarged spleen)." The pre-established primary endpoint in the trial is "Total Symptom Score (TSS) reduction of >50% over the 28 days immediately prior to the end of Week 24 compared to baseline TSS, using the Myelofibrosis Symptom Assessment Form (MFSAF)." Key secondary endpoints included Transfusion Independence (TI) Rate and Splenic Response Rate (SRR).
In a separate news release today, Sierra Oncology Inc. (SRRA:NASDAQ) reported "it entered into a term loan agreement with Oxford Finance, LLC that is designed to primarily support the commercial preparation and potential launch of momelotinib, an investigational agent for the treatment of myelofibrosis, a rare form of blood cancer."
Sierra Oncology's President and CEO Stephen Dilly, MBBS, Ph.D. commented in the announcement that the company's strong cash position, which as of December 31, 2021, exceeded $100 million, together with the term loan provided by Oxford Finance offers excellent support for moving forward towards an NDA filing and potential approval of momelotinib.
The terms of the loan facility incorporate specific funding arrangements based upon the company achieving certain milestones. Sierra advised that it drew down an initial $5 million at closing and will be able to increase the amount by another $70 million upon receipt of U.S. regulatory approval. In addition, Oxford may provide up to another $50 million in loans at its sole discretion. The firm added that its Series B Warrants are scheduled to expire in 75 days and that the full exercise of those warrants would provide Sierra with another $33.3 million in proceeds that could be utilized to fund the company's initiatives.
The company stated that momelotinib has already been granted Fast Track status the U.S. Food and Drug Administration (FDA) ant that it intends to submit a New Drug Application (NDA) with the FDA in Q2/22.
Sierra Oncology is a late-stage biopharma firm based in San Mateo, Calif. that is engaged in developing targeted treatments for rare types of cancer. The company's approach is to seek out compounds that target root causes of disease and integrate them with its cancer biology expertise to create new targeted therapies.
Sierra Oncology started the day with a market cap of around $233 million. SRRA shares opened 55% higher today at $24.07 (+$8.56, +55.19%) over yesterday's $15.51 closing price. The stock has traded today between $21.57 and $25.77 per share and is currently trading at $23.00 (+$7.49, +48.29%).
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