Sagimet Biosciences Announces Completion of Enrollment of 120 Patients for Phase 3 Clinical Trial by Its Partner Ascletis of Denifanstat Combined with Bevacizumab for Treatment of Recurrent Glioblastoma
27 Septembre 2023 - 10:05PM
Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage
biopharmaceutical company developing novel therapeutics targeting
dysfunctional metabolic pathways, today announced that its license
partner, Ascletis Bioscience Co. Ltd. (Ascletis), has enrolled 120
patients in its Phase 3 registration clinical trial of denifanstat
combined with bevacizumab for treatment of recurrent glioblastoma
(rGBM). Ascletis anticipates that this number of study subjects
will provide sufficient events for its planned interim analysis of
progression-free survival (PFS). Denifanstat is an oral, selective
small molecule inhibitor of fatty acid synthase (FASN), a key
enzyme which regulates de novo lipogenesis (DNL). Sagimet licensed
the rights to develop and commercialize denifanstat in the People’s
Republic of China, Hong Kong, Macau and Taiwan to Ascletis in
January 2019.
Sagimet’s FASCINATE-2 Phase 2b clinical trial for denifanstat in
liver biopsy-confirmed F2-F3 nonalcoholic steatohepatitis (NASH)
patients is fully enrolled and biopsy results are expected in the
first quarter of 2024. Sagimet also expects to report Phase 1
clinical trial results characterizing the pharmacokinetic profile
of denifanstat in patients with impaired hepatic function in the
first quarter of 2024.
“We congratulate Ascletis on achieving this important patient
enrollment milestone in its Phase 3 clinical trial of denifanstat
being conducted in China in patients with recurrent glioblastoma,”
stated David Happel, Chief Executive Officer of Sagimet. “Sagimet
looks forward to reporting biopsy results and other key endpoints
from our Phase 2 FASCINATE-2 trial for denifanstat in patients with
NASH in the first quarter of 2024, and, if the data is positive,
potentially advancing the program into a registrational Phase 3
trial.”
About Sagimet Biosciences
Sagimet is a clinical-stage biopharmaceutical
company developing novel therapeutics called fatty acid synthase
(FASN) inhibitors that target dysfunctional metabolic pathways in
diseases resulting from the overproduction of the fatty acid,
palmitate. Sagimet’s lead drug candidate, denifanstat, is an oral,
once-daily pill and selective FASN inhibitor in development for the
treatment of nonalcoholic steatohepatitis (NASH), for which there
are no treatments currently approved in the United States or
Europe. Denifanstat is currently being tested in FASCINATE-2, a
Phase 2b clinical trial in NASH with liver biopsy as the primary
endpoint. For additional information about Sagimet, please
visit www.sagimet.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of, and made pursuant to the safe harbor provisions of,
The Private Securities Litigation Reform Act of 1995. All
statements contained in this press release, other than statements
of historical facts or statements that relate to present facts or
current conditions, including but not limited to, statements
regarding: the expected timing of the presentation of data from
ongoing clinical trials, Sagimet’s clinical development plans and
related anticipated development milestones, Sagimet’s cash and
financial resources and expected cash runway. These statements
involve known and unknown risks, uncertainties and other important
factors that may cause Sagimet’s actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements. In some cases, these statements can be
identified by terms such as “may,” “might,” “will,” “should,”
“expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,”
“target,” “project,” “contemplate,” “believe,” “estimate,”
“predict,” “forecast,” “potential” or “continue” or the negative of
these terms or other similar expressions.
The forward-looking statements in this press release are only
predictions. Sagimet has based these forward-looking statements
largely on its current expectations and projections about future
events and financial trends that Sagimet believes may affect its
business, financial condition and results of operations. These
forward-looking statements speak only as of the date of this press
release and are subject to a number of risks, uncertainties and
assumptions, some of which cannot be predicted or quantified and
some of which are beyond Sagimet’s control, including, among
others: the clinical development and therapeutic potential of
denifanstat or any other drug candidates Sagimet may develop;
Sagimet’s ability to advance drug candidates into and successfully
complete clinical trials, including its FASCINATE-2 Phase 2b
clinical trial; Sagimet’s relationship with Ascletis, and the
success of its development efforts for denifanstat; the accuracy of
Sagimet’s estimates regarding its capital requirements; and
Sagimet’s ability to maintain and successfully enforce adequate
intellectual property protection. These and other risks and
uncertainties are described more fully in the “Risk Factors”
section of Sagimet’s most recent filings with the Securities
and Exchange Commission and available at www.sec.gov. You
should not rely on these forward-looking statements as predictions
of future events. The events and circumstances reflected in these
forward-looking statements may not be achieved or occur, and actual
results could differ materially from those projected in the
forward-looking statements. Moreover, Sagimet operates in a dynamic
industry and economy. New risk factors and uncertainties may emerge
from time to time, and it is not possible for management to predict
all risk factors and uncertainties that Sagimet may face. Except as
required by applicable law, Sagimet does not plan to publicly
update or revise any forward-looking statements contained herein,
whether as a result of any new information, future events, changed
circumstances or otherwise.
Contact:
Robert UhlManaging Director, ICR
Westwicke858.356.5932robert.uhl@westwicke.com
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