- 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 /CNW/ - 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 both top-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
yield top-line clinical data in Q4 2021."
About MOMENTUM Phase 3 Clinical Trial:
A
Randomized, Double-Blind, Phase 3 Study to Evaluate the Activity of
Momelotinib (MMB) versus Danazol (DAN) in Symptomatic, Anemic
Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera
(PV) Myelofibrosis, or Post Essential Thrombocythemia (ET)
Myelofibrosis who were Previously Treated with JAK Inhibitor
Therapy.
Sierra plans to launch the MOMENTUM Phase 3 clinical trial in Q4
2019. The randomized double-blind trial is designed to enroll 180
myelofibrosis patients who are symptomatic and anemic and have been
treated previously with a JAK inhibitor. Patients will be
randomized 2:1 to receive either momelotinib or danazol.
Danazol has been selected as an appropriate treatment comparator
given its use to ameliorate anemia in myelofibrosis patients, as
recommended by NCCN and ESMO guidelines. After 24 weeks of
treatment, patients on danazol will be allowed to crossover to
receive momelotinib.
The Primary Endpoint of the trial is the Total Symptom Score
(TSS) response rate of momelotinib compared to danazol at Week 24
(99% power; p-value < 0.05). Secondary and exploratory endpoints
include:
- Transfusion Independence (TI) rate at Week 24 (key secondary:
> 90% powered; p-value < 0.05),
- Splenic response rate (SRR) at Week 24 (> 90% powered;
p-value < 0.05),
- Duration of TSS response to Week 48,
- Other measures of anemia benefit, including Transfusion
Dependence response rate and various measures of cumulative
transfusion burden,
- Patient Reported Outcome measures of fatigue and physical
function.
About Dr. Srdan Verstovsek, Chief Investigator of the
MOMENTUM Phase 3 trial:
Dr. Srdan Verstovsek is Chief,
Section for Myeloproliferative Neoplasms, Department of Leukemia,
Division of Cancer Medicine, The University of
Texas MD Anderson Cancer Center, Houston. Dr.
Verstovsek is a world-renowned physician-scientist, and a leading
global authority on the treatment of myelofibrosis. His
clinical and translational research is focused on understanding the
biology of and developing new therapies for myeloproliferative
neoplasms (MPNs). He has been Principal investigator for more
than 50 clinical trials testing novel therapies for patients with
MPNs, and has published more than 400 peer-reviewed
manuscripts. He is the recipient of numerous awards including
the Celgene 2010 Young Investigator Award, 7th Annual Irwin H.
Krakoff Award for Excellence in Clinical and the Distinguished
Lecturer Award from the Society of Hematologic Oncology and the
Otis W. and Pearl L. Walters Faculty Achievement Award in Clinical
Research by MD Anderson Cancer Center. He was made a Member
of The American Society for Clinical Investigation in recognition
of his contributions as a physician-scientist.
Momelotinib Analyst & Investor Conference Call
The
company will be hosting an Analyst and Investor conference call at
6:00am ET on Wednesday, June 5, 2019,
to discuss next steps for momelotinib.
Domestic (Toll Free- US): 1-800-239-9838
International (Toll): 1-323-794-2551
Conference ID: 8101895
Webcast Link: www.sierraoncology.com
Direct Link: http://public.viavid.com/index.php?id=134831
Event registration and webcast information are available through
the Sierra Oncology website at www.sierraoncology.com. An archive
of the presentation will be accessible after the event through the
Sierra Oncology website.
About Momelotinib
Momelotinib, Sierra's lead drug
candidate, is a potent, selective and orally-bioavailable JAK1,
JAK2 & ACVR1 inhibitor with a differentiated therapeutic
profile in myelofibrosis encompassing robust constitutional symptom
improvements, a range of meaningful anemia benefits, including
eliminating or reducing the need for frequent blood transfusions,
and comparable spleen control to ruxolitinib. More than 1,200
subjects have received momelotinib since clinical studies began in
2009, including more than 800 subjects treated for myelofibrosis.
Momelotinib is covered by patents anticipated to provide potential
exclusivity to 2040 in the U.S.
About Sierra Oncology
Sierra Oncology is a clinical
stage drug development company advancing targeted therapeutics for
the treatment of patients with unmet medical needs in hematology
and oncology. In addition to our lead drug candidate, momelotinib,
Sierra's pipeline also includes SRA737 and SRA141. SRA737 is
a potent, highly selective, orally bioavailable small molecule
inhibitor of Checkpoint kinase 1 (Chk1), a key regulator of cell
cycle progression and the DNA Damage Response (DDR). At the 2019
ASCO Annual meeting, Sierra reported preliminary data for SRA737
including a 30% response rate in patients with anogenital cancer
treated with SRA737+LDG (low dose gemcitabine). SRA141 is a potent,
selective, orally bioavailable small molecule inhibitor of Cell
division cycle 7 kinase (Cdc7). Cdc7 is a key regulator of DNA
replication and is involved in the DDR network, making it a
compelling emerging target for the potential treatment of a broad
range of tumor types.
For more information, please 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 from current
data, anticipated clinical development activities, expected timing
of the initiation of, and results from, MOMENTUM, expectations
regarding data demonstrated by MOMENTUM, and potential benefits of
Sierra Oncology's product candidates. 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 may be unable to successfully develop and
commercialize product candidates, product candidates may not
demonstrate safety and efficacy or otherwise produce positive
results, Sierra Oncology may experience delays in the preclinical
and anticipated clinical development of its product candidates,
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's cash resources may be
insufficient to fund its current operating plans and it may be
unable to raise additional capital when needed, Sierra Oncology may
be unable to obtain and enforce intellectual property protection
for its technologies and product candidates 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.
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SOURCE Sierra Oncology