- Fast Track designation highlights the
potential for momelotinib to address the significant unmet needs of
patients with Intermediate/High-Risk myelofibrosis who have
previously received a JAK inhibitor -
- Fast Track Designation assures frequent communication with FDA,
often leading to earlier drug approval and access by patients -
- Sierra to host Analyst and Investor conference call at
6:00 am ET on Wednesday, June
5th –
- Presenting at the Jefferies Global Healthcare Conference
today at 8:00 am ET -
VANCOUVER, June 5, 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 the U.S. Food and Drug Administration (FDA) has granted Fast
Track designation to momelotinib, a JAK1, JAK2 and ACVR1 inhibitor,
for the treatment of patients with intermediate/high-risk
myelofibrosis who have previously received a JAK inhibitor.
"Fast Track designation for momelotinib highlights the serious
and significant unmet needs of patients with myelofibrosis who have
previously received a JAK inhibitor. These patients typically
suffer from uncontrolled constitutional symptoms, progressively
worsening anemia often resulting in transfusion dependency, and
enlarged spleens. Fast Track also recognizes the absence of
FDA-approved treatments for these patients and that momelotinib has
the potential to address their unmet needs," said Dr. Barbara Klencke, Chief Development Officer of
Sierra Oncology. "We look forward to continuing to work closely
with the FDA as we launch and conduct the MOMENTUM Phase 3 trial of
momelotinib, with the goal of bringing this important therapy to
patients expeditiously."
"We are very pleased that momelotinib has been granted Fast
Track designation by the FDA, which further reflects the
collaborative and constructive dialogue we have had with the Agency
concerning the advancement of momelotinib towards potential
registration," said Dr. Nick Glover,
President & CEO of Sierra Oncology.
About FDA Fast Track Designation:
The Fast
Track program facilitates the expedited development and review of
new drugs or biologics that are intended to treat serious or
life-threatening conditions and demonstrate the potential to
address unmet medical needs. Fast Track designation allows for
frequent communication and interactions with the review team at the
FDA throughout the drug development and review process, with the
goal of providing faster drug approval and greater patient
access.
A drug that receives Fast Track designation is
eligible for some or all of the following:
- More frequent meetings with FDA to discuss the drug's
development plan and ensure collection of appropriate data needed
to support drug approval
- More frequent written communication from FDA about such things
as the design of proposed clinical trials
- Eligibility for Accelerated Approval and Priority Review, if
relevant criteria are met
- Rolling Review, which means that a drug company can
submit completed sections of its Biologic License Application (BLA)
or New Drug Application (NDA) for review by FDA, rather than
waiting until every section of the NDA is completed before the
entire application can be reviewed.
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.
Dr. Srdan Verstovsek, MD, PhD, Chief, Section for
Myeloproliferative Neoplasms, Department of Leukemia, Division of
Cancer Medicine, The University of
Texas MD Anderson Cancer Center, Houston, Texas, has been named Chief
Investigator of the MOMENTUM Phase 3 study.
Momelotinib Analyst & Investor Conference Call
The
company will be hosting an Analyst and Investor conference call at
6:00 am 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.
Sierra Jefferies Presentation
Dr. Nick Glover, President and Chief Executive
Officer, will present an overview of the company and updates
concerning its clinical stage drug candidates, momelotinib and
SRA737, at 8:00 am ET on Wednesday, June 5,
2019 at the Jefferies Global Healthcare Conference being
held in New York.
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.
View original
content:http://www.prnewswire.com/news-releases/sierra-announces-momelotinib-granted-fda-fast-track-designation-300862225.html
SOURCE Sierra Oncology