Faron reports increased remission rate in trial for myelodysplastic syndrome candidate
Ella Day | August 7, 2025 | News story | Medical Communications, Research and Development | Faron Pharmaceuticals, Oncology, US Food and Drug Administration, acute myeloid leukemia, myelodysplastic syndrome
Faron Pharmaceuticals has reported a rise in complete remission (CR) rates among patients with frontline high-risk myelodysplastic syndrome (HR-MDS) in its ongoing phase 1/2 BEXMAB trial. The updated data show a CR rate of 43% – up from 28% in an earlier analysis – reinforcing the promise of its candidate as a therapy for this group of blood cancers.
The BEXMAB trial is evaluating bexmarilimab in combination with standard-of-care azacitidine in patients with HR-MDS and acute myeloid leukemia. The data was prepared in advance of an end-of-phase 2 meeting with the US Food and Drug Administration (FDA). Faron is preparing to propose a registrational trial with either CR or composite CR (cCR) as the primary endpoint to the administration.
Complete remission in HR-MDS indicates a return to normal bone marrow function and blood cell levels, assessed according to International Working Group criteria. The 43% CR rate observed in Faron’s BEXMAB study exceeds prior outcomes associated with azacitidine alone, which typically produce lower CR rates of between 16-17%.
Petri Bono, chief medical officer of Faron, said: “Seeing the CR rate strengthen over time to 43%, which complements the robust 50% cCR we have already reported, is very encouraging. It provides us with two compelling and clinically meaningful data sets for discussion with the FDA.”
Ella Day
7/8/25
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