- Momelotinib's demonstrable anemia benefit and
low myelosuppressive potential facilitate sustained dose intensity
and prolonged clinical activity -
- Long-term safety profile reinforces lack of
emergent or cumulative toxicity with extended
daily momelotinib administration -
VANCOUVER, May 14, 2020 /CNW/ - Sierra Oncology, Inc.
(SRRA), a late-stage drug development company focused on the
registration and commercialization of momelotinib, a JAK1, JAK2
& ACVR1 inhibitor with a potentially differentiated therapeutic
profile for the treatment of myelofibrosis, today announced that
Dose Intensity and Long-Term Safety data for momelotinib will be
presented in two posters at the 25th European Hematology
Association (EHA) Virtual Congress taking place from June 11-21, 2020.
"In these new analyses of data from the previously completed
Phase 3 SIMPLIFY studies, momelotinib displayed favorable long-term
efficacy, safety and tolerability consistent with its
differentiated pharmacological and clinical profile. These data
reinforce the remarkable durability of momelotinib treatment, which
was achieved while maintaining sustained active and well tolerated
dose intensity," said Dr. Barbara
Klencke, Chief Development Officer of Sierra Oncology.
"Specifically, momelotinib showed an absence of significant rates
of high-grade hematological and other toxicities, which reinforce
the compound's potential to safely and effectively address the
unmet needs of patients with intermediate/high risk myelofibrosis.
Importantly, no new safety signals or evidence of cumulative
toxicity were observed during extended momelotinib daily
dosing."
"Momelotinib's demonstrable anemia benefits facilitate sustained
dose intensity and prolonged clinical activity across the continuum
of JAK inhibitor naïve and previously JAK inhibitor treated
myelofibrosis patients. These properties are in stark contrast to
ruxolitinib, where progressive dose reductions due to induced or
exacerbated myelosuppression are common, resulting in markedly
diminished dose intensity compared to momelotinib," said Dr.
Mark Kowalski, Chief Medical Officer
of Sierra Oncology. "Critically, patients who subsequently switched
from ruxolitinib treatment to momelotinib achieved an immediate and
sustained improvement in both hemoglobin and platelets, and
generally went on to receive full-dose momelotinib over an extended
period, affirming momelotinib's potential to successfully treat
myelofibrosis patients with JAKi-induced hematological
toxicity."
The long-term safety data and dose intensity data to be reported
at EHA draw from the extensive clinical dataset available for
momelotinib from the two previously conducted SIMPLIFY Phase 3
studies and their subsequent ongoing extended treatment periods.
The SIMPLIFY-1 trial was conducted in JAKi-naïve myelofibrosis
patients (n=432) randomized 1:1 to momelotinib or ruxolitinib.
SIMPLIFY-2 was conducted in prior ruxolitinib-treated myelofibrosis
patients with hematological toxicity (n=156) randomized 2:1 to
momelotinib or best available therapy (consisting of ruxolitinib in
88% of patients). Patients randomized to ruxolitinib in SIMPLIFY-1
and best available therapy in SIMPLIFY-2 were eligible to
cross-over to momelotinib at the end of the 24-week randomized
treatment period in both studies, subsequently receiving
momelotinib for an extended treatment period.
Sierra is currently enrolling patients in the MOMENTUM clinical
trial for patients with myelofibrosis. The randomized double-blind
global Phase 3 trial is designed to confirm the efficacy of
momelotinib on myelofibrosis symptoms, transfusion independence and
splenomegaly, as compared to danazol. The trial is targeting
enrollment of 180 myelofibrosis patients who are symptomatic,
anemic and have been treated previously with a JAK inhibitor. The
Primary Endpoint of the trial is the Total Symptom Score (TSS)
response rate of momelotinib compared to danazol at Week 24 (99%
power; 2-sided alpha of 0.05). Data from MOMENTUM, along with data
from more than 820 myelofibrosis patients previously treated with
momelotinib in prior clinical studies, will form the basis of the
global registration strategy for momelotinib.
About the EHA Posters
Title: Long term Safety of
Momelotinib in JAKi Naïve and Previously JAKi Treated
Intermediate/High Risk Myelofibrosis Patients
Lead Author: Prof. Claire Harrison,
Guy's and St. Thomas' NHS
Foundation Trust, London, United
Kingdom
Session Title: Myeloproliferative neoplasms - Clinical
Poster No.: EP1113
Title: Momelotinib Dose-Intensity is Maintained in JAKi Naïve
and Previously JAKi Treated Intermediate/High Risk Myelofibrosis
Patients
Lead Author: Dr. Vikas Gupta,
Princess Margaret Cancer Centre, Toronto,
ON, Canada
Session Title: Myeloproliferative neoplasms - Clinical
Poster No.: EP1103
The accepted abstracts are now available online on the EHA
conference websites at https://ehaweb.org/
Both e-posters will be made available through the on-demand
Virtual Congress platform and at www.sierraoncology.com as of
Friday, June 12, 08:30 CEST.
About Sierra Oncology
Sierra Oncology is a late stage
drug development company focused on achieving the successful
registration and commercialization of momelotinib, a potent,
selective and orally-bioavailable JAK1, JAK2 & ACVR1 inhibitor
with a targeted mechanism of action that enables it to address all
three key drivers of myelofibrosis. Momelotinib's differentiated
therapeutic profile encompasses 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 820 patients treated for
myelofibrosis.
Sierra has launched MOMENTUM, a randomized double-blind Phase 3
clinical trial designed to enroll 180 myelofibrosis patients who
are symptomatic and anemic, and who have been treated previously
with a JAK inhibitor. The U.S. Food and Drug Administration has
granted Fast Track designation to momelotinib. Momelotinib is
protected by patents anticipated to provide potential exclusivity
to 2040 in the United States and
Europe (inclusive of potential
Patent Term Extension or Supplementary Protection Certificate).
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, and potential
benefits 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 risk that 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, the risk that disruptions and impacts of COVID-19 will
be significant and lengthy, Sierra Oncology may be unable to
successfully develop and commercialize momelotinib,
momelotinib may not demonstrate safety and efficacy or
otherwise produce positive results, Sierra Oncology may experience
delays in the clinical development of momelotinib, 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 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.
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SOURCE Sierra Oncology