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Agios Announces FDA Clearance of Investigational New Drug Application for AG-946, a Next-Generation PKR Activator
– Phase 1 Healthy Volunteers Study Expected to Begin in Mid-Year 2020 – CAMBRIDGE, Mass., March 23, 2020 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc.
About this update from Agios Pharmaceuticals, Inc.
[{"type":"text","content":"– Phase 1 Healthy Volunteers Study Expected to Begin in Mid-Year 2020 –\n CAMBRIDGE, Mass., March 23, 2020 (GLOBE NEWSWIRE) -- 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 mat...