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(Sharecast News) - Faron Pharmaceuticals announced further encouraging data from the first phase of its 'BEXMAB' trial on Monday, targeting higher-risk (HR) myelodysplastic syndrome (MDS) patients who had failed prior hypomethylating agent (HMA) treatment.
The AIM-traded firm said the study, now advanced into its second phase, aimed to address a critical gap in treatment options for this patient population.
It said the latest findings revealed a notable increase in the number of patients responding to treatment and demonstrating sustained remission.
Among the initial phase one HR HMA-failed MDS patients, four out of five were still alive after an eight-month follow-up period.
Although median overall survival (mOS) data was pending, the observed survival benefit surpassed conventional benchmarks, providing an optimistic outlook for patient outcomes compared to current standards of care.
Additionally, the enrollment of three more HMA-failed HR MDS patients brought the total to eight, with seven out of eight patients showing a positive response to treatment, yielding an overall response rate (ORR) of 87.5%.
Notably, responses included complete response (CR), marrow complete remissions (mCR), partial response (PR), haematological improvements, and stable disease (SD).
Despite one patient discontinuing early due to an unrelated serious adverse event (SAE), the observed efficacy of bexmarilimab in combination with azacitidine still showed potential as a viable therapeutic option for the challenging patient population.
"These data are really remarkable and confirm our belief that we may finally have a treatment for this underserved patient population," said chief executive officer Dr Markku Jalkanen.
"The data are strongly supportive that a registrational trial would be positive against any contemporary comparator when the final endpoint is survival.
"We eagerly await completion of the phase two part of the BEXMAB study so we can take these data to the FDA as soon as possible."
At 1435 GMT, shares in Faron Pharmaceuticals were up 28.57% at 180p.
Reporting by Josh White for Sharecast.com.
