The US Food and Drug Administration (FDA) has granted orphan drug designation to ofirnoflast (HT-6184), an investigational therapy for myelodysplastic syndromes (MDS).
Ofirnoflast, a NEK7 inhibitor, is manufactured by clinical-stage biopharmaceutical company Halia Therapeutics. The therapy completed a phase 2 study evaluating safety and outcomes in MDS.
“This designation underscores the potential of our approach in myelodysplastic syndromes and supports our commitment to developing new treatment options for patients living with MDS,” said David Bearss, PhD, CEO of Halia Therapeutics, in a company release announcing the designation. “Ofirnoflast represents a first-in-class approach to modulating inflammasome biology, an upstream driver of inflammation, with the goal of restoring healthy bone marrow function.”
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