Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON) announced the completion of patient enrollment for its BEXMAB Phase II study. The trial is evaluating bexmarilimab in patients with refractory or relapsed myelodysplastic syndrome (r/r MDS) and frontline high-risk (HR) MDS. Topline efficacy and safety data are expected in April 2025, with detailed findings to be presented at major medical conferences.
The BEXMAB trial includes approximately 35 r/r MDS patients and 20 frontline HR MDS patients. Among the r/r MDS cohort, 32 patients received either 3mg/kg or 6mg/kg doses of bexmarilimab, following FDA Project Optimus guidance, while three patients received a 1mg/kg dose in Phase I. A similar dose distribution will be reported for the HR MDS cohort.
Promising Interim Results
Interim results from the BEXMAB Phase II study, presented at the 66th American Society of Hematology (ASH) Annual Meeting in December 2024, demonstrated an 80% objective response rate (ORR) in a 20-patient cohort. This compares favorably to the 0% to 20% ORR typically observed with existing alternatives for this patient group. The estimated median overall survival for 20 r/r MDS patients in the study was 13.4 months, significantly exceeding the typical five to six months seen with standard treatments.
Future Plans
Faron is continuing to enroll patients with chronic myelomonocytic leukemia (CMML) and is considering expanding recruitment for r/r MDS patients under the current protocol. The expansion would support patient access and strengthen the dataset for future regulatory submissions.
Management Commentary
"Our BEXMAB Phase II trial has progressed as planned and our focus now is to take this data to the FDA and fine tune the registrational approach with the agency," said chief executive officer Dr. Juho Jalkanen. "We are committed to rapidly advancing bexmarilimab through clinical development, to bring it to treatment resistant MDS patients as soon as possible."
