Agios Announces FDA Clearance of Investigational New Drug Application for AG-946, a Next-Generation PKR Activator
March 23 2020 - 7:00AM
Agios Pharmaceuticals, Inc. (NASDAQ: AGIO) today announced that the
U.S. Food and Drug Administration (FDA) has cleared the company’s
investigational new drug (IND) application for AG-946, a
next-generation pyruvate kinase-R (PKR) activator. FDA has
completed its 30-day safety review and granted approval to proceed
with the proposed Phase 1 healthy volunteers study.
“As our eighth IND in just 10 years, AG-946 demonstrates the
consistent productivity of our research engine and our leadership
in the understanding of PKR activation,” said Bruce Car, Ph.D.,
chief scientific officer at Agios. “By advancing AG-946 into the
clinic, we have the opportunity to expand our PKR activation
program and build on the expertise we established with our lead PKR
activator, mitapivat, across a range of hemolytic anemias.”
Agios expects to initiate the AG-946 Phase 1 study in mid-year
2020. The company continues to monitor the potential impact of the
COVID-19 pandemic on clinical trial initiations and will provide
additional updates as needed.
About AgiosAgios is focused on discovering and
developing novel investigational medicines to treat malignant
hematology, solid tumors and rare genetic diseases through
scientific leadership in the field of cellular metabolism. In
addition to an active research and discovery pipeline across these
three therapeutic areas, Agios has two approved oncology precision
medicines and multiple first-in-class investigational therapies in
clinical and/or preclinical development. For more information,
please visit the company's website at www.agios.com.
Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Such forward-looking statements include those
regarding Agios’ plans, strategies and expectations for the
clinical development of its AG-946 program. The words “expect,”
“opportunity” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Such statements are
subject to numerous important factors, risks and uncertainties that
may cause actual events or results to differ materially from Agios'
current expectations and beliefs. For example, there can be no
guarantee that any product candidate Agios is developing will
successfully commence or complete necessary preclinical and
clinical development phases, or that development of any of Agios'
product candidates will successfully continue. There can be no
guarantee that any positive developments in Agios' business will
result in stock price appreciation. Management's expectations and,
therefore, any forward-looking statements in this press release
could also be affected by risks and uncertainties relating to a
number of other important factors, including: Agios' results of
clinical trials and preclinical studies, including subsequent
analysis of existing data and new data received from ongoing and
future studies; the content and timing of decisions made by the
U.S. FDA, the EMA or other regulatory authorities, investigational
review boards at clinical trial sites and publication review
bodies; Agios' ability to obtain and maintain requisite regulatory
approvals and to enroll patients in its planned clinical trials;
unplanned cash requirements and expenditures; competitive factors;
Agios' ability to obtain, maintain and enforce patent and other
intellectual property protection for any product candidates it is
developing; Agios' ability to maintain key collaborations; and
general economic, market and global health conditions. These and
other risks are described in greater detail under the caption "Risk
Factors" included in Agios’ public filings with the Securities and
Exchange Commission. Any forward-looking statements contained in
this press release speak only as of the date hereof, and Agios
expressly disclaims any obligation to update any forward-looking
statements, whether as a result of new information, future events
or otherwise, except as required by law.
Contacts
Investors:Holly Manning, 617-844-6630Director,
Investor RelationsHolly.Manning@agios.com
Media:Jessica Rennekamp, 857-209-3286Associate
Director, Corporate CommunicationsJessica.Rennekamp@agios.com
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