FDA grants IMR-687 rare pediatric disease designation

Imara Inc. (Cambridge, Mass.) said FDA granted rare pediatric disease designation to IMR-687 to treat sickle cell disease (SCD). Imara said it is the first SCD candidate to receive the designation from the agency.

The phosphodiesterase-9 (PDE-9) inhibitor has Orphan Drug designation from FDA in the indication and is in Phase I testing in healthy volunteers. Imara plans to start a Phase IIa trial of IMR-687 in adults with SCD later this year and a Phase II trial in pediatric patients next year...