The US Food and Drug Administration (FDA) has granted Orphan Drug designation for bexmarilimab for the treatment of patients with myelodysplastic syndromes (MDS).
Bexmarilimab, an immunotherapy targeting the Clever-1 receptor, is administered with azacitidine in the BEXMAB study, according to a press release published by Faron Pharmaceuticals, the drug’s manufacturer.
The trial tests its safety and efficacy in patients with relapsed or refractory MDS, showing an 80% response rate in patients who failed treatment with a hypomethylating agent.
Top-line efficacy results for frontline and relapsed/refractory MDS are expected in April 2025, the company reported.
