Faron identifies final patient in BEXMAB phase two study
By Josh White
Date: Friday 31 Jan 2025
(Sharecast News) - Faron Pharmaceuticals announced on Friday that it has identified the final patient for its BEXMAB phase two dose optimisation study in refractory or relapsed myelodysplastic syndrome (r/r MDS) and its phase one and two study in frontline high-risk (HR) MDS.
The AIM-traded company said it expected to report topline efficacy and safety data in April, with detailed findings to be presented at major medical conferences.
It said the reportable dataset would include approximately 35 r/r MDS patients and 20 frontline HR MDS patients.
Among the r/r MDS cohort, 32 patients had been treated with three milligrams or six milligrams per kilogram doses of bexmarilimab in accordance with FDA Project Optimus guidance, while three patients received a one milligram per kilogram dose in phase one.
A similar dose distribution would be reported for the HR MDS cohort.
Interim results from the BEXMAB phase two study, presented at the 66th American Society of Hematology Annual Meeting in December, showed an 80% objective response rate in a 20-patient cohort.
That, the board said, compared favorably to alternative treatments, which had historically reported objective response rates of 0% to 20% without deep and durable remissions.
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.
Faron said it was continuing to enrol patients with chronic myelomonocytic leukemia (CMML) and was 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.
"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.
"I want to express my sincere gratitude to all the stakeholders working on the BEXMAB trial, especially our hardworking employees, study site professionals and investigators, but most of all the patients and their loved ones."
At 1017 GMT, shares in Faron Pharmaceuticals were down 2.57% at 170.5p.
Reporting by Josh White for Sharecast.com.
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