Sierra Oncology Announces Submission of New Drug Application for Momelotinib to US Food & Drug Administration
June 17 2022 - 7:00AM
Business Wire
– Submission seeks approval of momelotinib for
the treatment of myelofibrosis –
Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage
biopharmaceutical company on a mission to deliver transformative
therapies for rare cancers, today announced the company has
submitted a New Drug Application (NDA) to the US Food and Drug
Administration (FDA) for momelotinib, an ACVR1 / ALK2, JAK1 and
JAK2 inhibitor in development for the treatment of
myelofibrosis.
“Today is truly momentous for everyone at Sierra Oncology and
the patients we serve. This team designed a targeted study to
address the highest unmet need and delivered incredible results in
the midst of a pandemic. We are thrilled to submit this NDA on
behalf of myelofibrosis patients and look forward to working with
the FDA over the coming months,” said Stephen Dilly, MBBS, PhD,
President and Chief Executive Officer of Sierra Oncology. “We are
immensely grateful to the patients and investigators who
participated in momelotinib trials over the years, making it
possible to achieve this milestone.”
The NDA submission is based on the results from several Phase 2
and Phase 3 studies, including the recently completed MOMENTUM
study. As with all new drug applications, the company expects the
FDA to respond as to whether this submission is accepted within 60
days. Assuming the submission is accepted and a subsequent approval
is granted, commercial launch of momelotinib is anticipated in
2023.
About the Pivotal MOMENTUM Clinical Trial MOMENTUM is a
global, randomized, double-blind Phase 3 clinical trial of
momelotinib versus danazol in patients with myelofibrosis who were
symptomatic and anemic, and had been previously treated with an
FDA-approved JAK inhibitor. The study was designed 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). Results from the
MOMENTUM study were presented at the 2022 Annual Meeting of the
American Society of Clinical Oncology.
The primary endpoint of the study 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). Secondary
endpoints included Transfusion Independence (TI) rate for
>12 weeks immediately prior to the
end of Week 24 with Hgb levels ≥ 8 g/dL, and Splenic Response Rate
(SRR) based on splenic volume reduction of >35% at Week 24. The study enrolled 195
patients based on a planned 180 patients across 21 countries.
Danazol was selected as the treatment comparator given its use
to ameliorate anemia in patients with myelofibrosis, as recommended
by National Comprehensive Cancer Network (NCCN) and European
Society of Medical Oncology (ESMO) guidelines. Patients were
randomized 2:1 (MMB n = 130 and DAN n = 65) to receive either
momelotinib or danazol. After 24 weeks of treatment, patients on
danazol were allowed to crossover to receive momelotinib. Early
cross-over to momelotinib was available for confirmed symptomatic
splenic progression.
About Momelotinib Momelotinib is a potent, selective and
orally bioavailable ACVR1 / ALK2, JAK1, JAK2 inhibitor under
investigation for the treatment of myelofibrosis in symptomatic,
anemic patients previously treated with an approved JAK inhibitor.
More than 1,200 subjects have received momelotinib since clinical
studies began in 2009, including approximately 1,000 patients
treated for myelofibrosis, several of whom remain on treatment for
over 12 years. Momelotinib is the first and only JAK inhibitor to
demonstrate positive data for all key hallmarks of the
disease—symptoms, splenic response and anemia.
About Myelofibrosis Myelofibrosis is a rare blood cancer
that results from dysregulated JAK-STAT signaling and is
characterized by constitutional symptoms, splenomegaly (enlarged
spleen) and progressive anemia. From prior studies with
momelotinib, we know approximately half of myelofibrosis patients
are moderately to severely anemic when eligible for JAK inhibitor
treatment. Furthermore, currently approved JAK inhibitors only
address symptoms and splenomegaly and are myelosuppressive. This
can lead to worsening anemia, resulting in dose reductions that
potentially reduce treatment effect.
About Sierra Oncology Sierra Oncology is a late-stage
biopharmaceutical company on a mission 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 potential
and future success of momelotinib, statements by Sierra Oncology’s
President and Chief Executive Officer, the timing of the FDA’s
response to Sierra Oncology’s NDA, the possibility of an approval
of momelotinib and the timing of a commercial launch of
momelotinib. 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 uncertainties
associated with the regulatory approval process, the risk that
Sierra Oncology may be unable to successfully commercialize
momelotinib, 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
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version on businesswire.com: https://www.businesswire.com/news/home/20220617005035/en/
Investor Contact DeDe Sheel
415.732.9828 dsheel@sierraoncology.com
Media Contact Lauren Musto
615.351.7777 lmusto@sierraoncology.com
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