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 –
“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
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.
Agios 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 Statements
This 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
Director, Investor Relations
Associate Director, Corporate Communications
Source: Agios Pharmaceuticals, Inc.