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TURKU, FINLAND - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company, has announced the identification of the final patient for its BEXMAB Phase II study in refractory or relapsed myelodysplastic syndrome (r/r MDS) and the Phase I/II study in frontline high-risk (HR) MDS. The company expects to release topline efficacy and safety data in April 2025, with detailed results to be shared at subsequent medical conferences.
The study includes approximately 35 patients with r/r MDS and 20 patients with frontline HR MDS. The r/r MDS cohort comprises 32 patients treated with 3mg/kg or 6mg/kg doses of bexmarilimab, following the FDA’s Project Optimus guidance, and three patients treated with a 1mg/kg dose in Phase I. A similar distribution of doses is applied to the frontline HR MDS cohort.
Chief Medical (TASE:PMCN) Officer Dr. Petri Bono highlighted the achievement as a reflection of the company’s commitment to addressing the urgent medical needs of MDS patients. The Phase II Interim Results, presented in December 2024 at the 66th American Society of Hematology Annual Meeting, showed an 80% objective response rate (ORR) for bexmarilimab, a significant improvement compared to the 0-20% ORR observed with existing treatments. The interim data also indicated a median overall survival of 13.4 months for r/r MDS patients, surpassing the historical standard of care.
Faron is also considering expanding the trial to include more r/r MDS patients and CMML patients, aiming to strengthen the data set for regulatory purposes. CEO Dr. Juho Jalkanen expressed gratitude to all stakeholders involved in the BEXMAB trial and emphasized the company’s dedication to advancing bexmarilimab through clinical development to provide a new treatment option for MDS patients.
This news is based on a press release statement from Faron Pharmaceuticals.
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