The Food and Drug Administration (FDA) has granted Fast Track status to IMR-687 (Imara Inc.), an investigational treatment for sickle cell disease.

IMR-687 is an orally-administered, highly selective inhibitor of phosphodiesterase 9 (PDE9) designed to reduce red blood cell sickling and adherence of white blood cells to the blood vessel wall. It is currently being investigated in a phase 2a, placebo-controlled, clinical trial involving 54 patients with sickle cell anemia; a phase 1 trial conducted in healthy volunteers found IMR-687 to be well tolerated.

“We believe that IMR-687 has the potential to transform outcomes for people living with sickle cell disease,” said Rahul D. Ballal, Chief Executive Officer of Imara. “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.”

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IMR-687 has also been granted Orphan Drug and Rare Pediatric designations.

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