In This Article:
TURKU, FI / ACCESS Newswire / April 15, 2025 / Faron Pharmaceuticals (HEL:FARON)(LSE:FARN) - Inside Information: BEXMAB Phase II trial met its primary endpoint in treatment-resistant High Risk MDS (r/r HR MDS)
Key Highlights
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Topline read-out from the Phase II BEXMAB trial confirms earlier positive findings in both frontline and relapsed/refractory higher-risk myelodysplastic syndrome (HR MDS) patients
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The combination of bexmarilimab and azacitidine remains very well tolerated
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Full data has been submitted to the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting
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Faron is planning for a Phase III trial, pending U.S Food and Drug Administration (FDA) End of Phase II meeting Feedback
TURKU, FINLAND - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, today announced positive topline results of the BEXMAB trial, which shows a high overall response rate (ORR) among both frontline as well as relapsed/refractory (r/r) HR MDS patients treated with a combination of bexmarilimab and azacitidine.
According to this first fully enrolled Phase II analysis, the treatment continues to be well tolerated without any dose-limiting toxicity in r/r HR MDS patients with no other currently effective treatment options. A high objective response rate of 63% was observed in this initial data cut. The median overall survival remains at the same level as previously reported. Among treatment naïve (frontline phase 1) HR MDS patients, an ORR of 76% was observed. Many patients are still early in their treatment, which means responses may deepen over time and results are subject to minor changes as data matures. The full data has been submitted to the 2025 ASCO Annual Meeting.
"This is one of the strongest data set ever seen in an all-comer population of treatment resistant HR MDS", says Dr. Juho Jalkanen, CEO of Faron Pharmaceuticals. "There is a significant unmet need in the treatment of HR MDS, as drug development in HR MDS and macrophage re-programming has proven to be extremely challenging, with a lot of previous failures. What really makes bexmarilimab stand out in this field is its good safety profile combined with very high efficacy especially in last line HR MDS. This gives us conviction that bexmarilimab is the long-awaited drug to overcome treatment resistance".
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Riina Tuominen
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Kare Laukkanen
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