Syros Announces First Patient in Dose Confirmation Study of SY-2101, a Novel Oral Form of Arsenic Trioxide, in Acute Promyelocytic Leukemia
September 29 2021 - 8:00AM
Business Wire
Confirmatory Dose and PK Data Expected in First
Half of 2022, with a Phase 3 Trial Expected to Begin in 2022
Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development
of medicines that control the expression of genes, today announced
that the first patient has been dosed in the dose confirmation
study of SY-2101, a novel oral form of arsenic trioxide (ATO). The
trial will evaluate the pharmacokinetics (PK), safety, and
tolerability of SY-2101 to confirm the optimal dose to advance into
a planned Phase 3 clinical trial in newly diagnosed acute
promyelocytic leukemia (APL) patients.
“The current standard of care cures most patients but is
tremendously burdensome, requiring regular and lengthy infusions of
an IV formulation of ATO over nearly a yearlong course of
treatment,” said Farhad Ravandi, M.D., Professor of Medicine, Chief
of Section of Acute Myeloid Leukemia, Department of Leukemia at The
University of Texas – MD Anderson Cancer Center. “An oral form of
ATO that offers similar efficacy while dramatically reducing the
treatment burden would represent a major advance for APL patients.
The preliminary Phase 1 data for SY-2101 are very promising, and I
look forward to its continued advancement in the current and future
studies.”
APL is a well-defined subtype of acute myeloid leukemia (AML),
which accounts for about 10% of AML cases, with approximately 2,000
APL patients diagnosed annually in the United States and Europe. An
intravenously administered formulation of ATO is approved for use
in combination with All-Trans-Retinoic-Acid (ATRA) in newly
diagnosed APL and, while curative in more than 80% of patients, its
administration requires up to 140 infusions over the typical
10-month course of induction and consolidation treatment. In an
earlier Phase 1 clinical trial, SY-2101, which is dosed once daily,
demonstrated oral bioavailability, PK exposures similar to IV ATO,
and a generally well-tolerated safety profile.
"We are thrilled to now be dosing patients in our dose
confirmation study of SY-2101,” said David A. Roth, M.D., Chief
Medical Officer at Syros. “This milestone represents an important
step toward delivering a new option for people with APL and a
meaningful advance in our efforts to build a leading portfolio of
targeted hematology therapies. We believe SY-2101 could quickly
become the new standard of care for APL by offering patients
similar efficacy with a substantially more accessible and
convenient therapy. We plan to move swiftly from our dose
confirmation study into a Phase 3 trial next year, with the goal of
filing a New Drug Application (NDA) in 2024.”
The dose confirmation study is expected to enroll up to 24
patients with newly diagnosed APL and will evaluate safety,
tolerability, and PK as well as the effect of food on the
absorption of SY-2101. Patients will be enrolled during the
consolidation phase of their APL treatment and will receive single
doses of SY-2101 in a fasted state, SY-2101 in a fed state, and IV
ATO. Patients will then have the option to roll over into a
multiple-dose cohort to receive either SY-2101 or IV ATO, which
will provide additional data on the steady state PK and safety of
SY-2101 in comparison to IV ATO. Syros expects to report data from
this study in the first half of 2022.
Based on the results of the dose confirmation study, Syros
expects to initiate a Phase 3 clinical trial in newly diagnosed APL
patients. Based on input from the FDA, Syros believes molecular
complete response rate and event-free survival in comparison to
historical control data with IV ATO may support accelerated and
full approval, respectively.
About Syros Pharmaceuticals Syros is redefining the power
of small molecules to control the expression of genes. Based on its
unique ability to elucidate regulatory regions of the genome, Syros
aims to develop medicines that provide a profound benefit for
patients with diseases that have eluded other genomics-based
approaches. Syros is advancing a robust clinical-stage pipeline,
including: tamibarotene, a first-in-class oral selective RARα
agonist in RARA-positive patients with higher-risk myelodysplastic
syndrome and acute myeloid leukemia; SY-2101, a novel oral form of
arsenic trioxide in patients with acute promyelocytic leukemia; and
SY-5609, a highly selective and potent oral CDK7 inhibitor in
patients with select solid tumors and blood cancers. Syros also has
multiple preclinical and discovery programs in oncology and
monogenic diseases. For more information, visit www.syros.com and
follow us on Twitter (@SyrosPharma) and LinkedIn.
Cautionary Note Regarding Forward-Looking Statements This
press release contains forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995,
including without limitation statements regarding Syros’s clinical
development plans with respect to SY-2101, the timing of
anticipated data readouts from the dose confirmation study of
SY-2101, the anticipated timing for initiating a Phase 3 trial of
SY-2101, the potential submission of a new drug application and the
likelihood of regulatory approval, the and the ability of SY-2101
to have a benefit for patients. The words ‘‘anticipate,’’
‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’
“hope,” ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’
‘‘project,’’ ‘‘target,’’ ‘‘should,’’ ‘‘would,’’ and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Actual results or events could differ materially
from the plans, intentions and expectations disclosed in these
forward-looking statements as a result of various important
factors, including Syros’ ability to: advance the development of
SY-2101 under the timelines it projects in current and future
clinical trials; demonstrate in any current and future clinical
trials the requisite safety, efficacy and combinability of SY-2101;
sustain the responses seen to date with SY-2101; obtain and
maintain patent protection for its drug candidates and the freedom
to operate under third party intellectual property; obtain and
maintain necessary regulatory approvals; identify, enter into and
maintain collaboration agreements with third parties; manage
competition; manage expenses; raise the substantial additional
capital needed to achieve its business objectives; attract and
retain qualified personnel; and successfully execute on its
business strategies; risks described under the caption “Risk
Factors” in Syros’ Annual Report on Form 10-K for the year ended
December 31, 2020 and Quarterly Report on Form 10-Q for the quarter
ended June 30, 2021, each of which is on file with the Securities
and Exchange Commission; and risks described in other filings that
Syros makes with the Securities and Exchange Commission in the
future. In addition, the extent to which the COVID-19 pandemic
continues to impact Syros’ workforce and its clinical trial
operations activities, and the operations of the third parties on
which Syros relies, will depend on future developments, which are
highly uncertain and cannot be predicted with confidence, including
the duration and severity of the pandemic, additional or modified
government actions, and the actions that may be required to contain
the virus or treat its impact. Any forward-looking statements
contained in this press release speak only as of the date hereof,
and Syros expressly disclaims any obligation to update any
forward-looking statements, whether because of new information,
future events or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20210929005020/en/
Media Contact Courtney Solberg Syros Pharmaceuticals
917-698-9253 csolberg@syros.com
Investor Contact Hannah Deresiewicz Stern Investor
Relations, Inc. 212-362-1200 hannah.deresiewicz@sternir.com
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