By Josh White
Date: Wednesday 11 Oct 2023
LONDON (ShareCast) - (Sharecast News) - Faron Pharmaceuticals announced encouraging updated data from its ongoing phase one and two 'BEXMAB' study into relapsed or refractory (r/r) acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS) treatments on Wednesday.
The AIM-traded firm said the study was scrutinising the efficacy of bexmarilimab in combination with standard of care (SoC) for patients who had not responded to hypomethylating agents (HMAs).
It said the fresh data aligned with previous results' high objective response rate (ORR), offering hope for individuals affected by these blood cancers.
Out of 22 patients who had undergone at least two treatment cycles, encompassing 12 with r/r AML and 10 with MDS, eight out of 11 achieved complete remission in the bone marrow, which may or may not be accompanied by blood count recovery.
The most noteworthy ORR was recorded among HMA-failed MDS patients, with a robust 80%, or four out of five patients.
Faron said the amalgamated study ORR remained elevated at 50%, or 11 out of 22 patients, across all patient groups who had received two or more treatment cycles in the combination regimen.
Additionally, three-quarters of patients showed reduced blast or immature blood cell counts.
As of 5 October, 29 patients had been enrolled into the doublet cohort.
In addition to its promising efficacy, bexmarilimab demonstrated a respectable safety profile, showing no dose-limiting toxicity at all tested dose levels.
While 18 drug-related events were recorded, the majority were below grade three in severity.
Of the events, five were reported as grade three or above, including immune-related events and an instance of increased liver enzymes.
"The emerging data from phase one and two continue to be extremely promising, showing continued good safety, encouraging efficacy and long durations of response," said chief executive officer Dr Markku Jalkanen.
"These results strongly support the planned next step of beginning enrollment of the phase two part of the BEXMAB study.
"We believe that bexmarilimab has the potential to provide better patient outcomes and improve the quality of life of those suffering from relapsed or refractory AML and MDS, which are conditions with dire prognosis and limited new therapies in the last decades."
At 1351 BST, shares in Faron Pharmaceuticals were down 5.66% at 330.2p.
Reporting by Josh White for Sharecast.com.
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