Imara announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to IMR-687, the company’s lead product candidate for the treatment of sickle cell disease. IMR-687 is currently being evaluated in a multi-national Phase 2a clinical trial in adult patients.

"We believe that IMR-687 has the potential to transform outcomes for people living with sickle cell disease. It has been designed as an oral, once-daily therapy with a dual mechanism of action to address both red blood cell and white blood cell pathologies associated with the disease," said Rahul D. Ballal, Chief Executive Officer of Imara. "The Fast Track designation granted by the FDA for IMR-687 is designed to allow us to advance this novel, investigative therapy more rapidly through increased opportunities for dialogue and collaboration with the Agency."

Fast Track designation aims to facilitate the development and expedite the review of drugs to treat serious conditions where an unmet medical need exists, with the goal of getting important new therapeutics to patients earlier.

Sickle cell disease is a rare, genetically inherited condition that alters hemoglobin, the protein in red blood cells that transports oxygen throughout the body. The altered hemoglobin distorts red blood cells into a sickle, or crescent, shape. Painful episodes can occur when sickled red blood cells, which are stiff and inflexible, get stuck in small blood vessels. These episodes deprive tissues and organs of oxygen-rich blood and can lead to vaso-occlusive crisis (VOC), acute chest syndrome (ACS), and permanent damage to organs including the liver, spleen, kidney and brain.

Sickle cell disease represents a critical unmet medical need globally, as a rare disease in many parts of the world including in the United States and as an endemic condition in certain African countries.

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