Faron Pharmaceuticals Limited (AIM:FARN, OTC:FPHAF)'s chief executive Dr Markku Jalkanen has described as "extremely encouraging" emerging data from the company's ongoing phase I/II trial.
Its BEXMAB study is evaluating the efficacy of bexmarilimab in treating acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS).
These are severe blood disorders that often resist standard treatments. The clinical evaluation has shown that bexmarilimab achieved a 50% remission rate among 22 patients who had relapsed or were refractory to standard treatments, including hypomethylating agents (HMAs).
Of the 22 patients, eight achieved complete remission, indicating that their symptoms were entirely eradicated or significantly reduced.
This is particularly noteworthy as these patients had previously failed to respond to standard treatments, making them difficult cases with limited therapeutic options.
The study also revealed that bexmarilimab was exceptionally effective in a subgroup of patients who had not responded to HMAs, a common medication for MDS.
In this cohort, four out of five patients showed a positive response, translating to an 80% overall response rate. This high rate of response in a typically resistant group suggests that bexmarilimab could offer a new avenue of treatment for patients who have exhausted other options.
"The emerging data from phase I/II continue to be extremely promising, showing continued good safety, encouraging efficacy and long durations of response," said CEO Jalkanen.
"These results strongly support the planned next step of beginning enrollment of the phase II 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/refractory AML and MDS, which are conditions with dire prognosis and limited new therapies in the last decades."
In terms of safety, bexmarilimab was well-tolerated across all tested dose levels. No dose-limiting toxic effects were observed, making it a potentially safer alternative to existing treatments.
While there were 18 drug-related events reported, the majority were below Grade 3 in severity, and only five were reported as Grade 3 and above. These included immune-related events but were not considered severe enough to limit the drug's dosage.