Proactive Investors - Faron Pharmaceuticals Limited (LON:FARN) told investors it is “extremely encouraged” by the progress of its Phase I/II study of Bexmarilimab, which is highlighted as showing continued efficacy signals.
The company, in a stock market statement, today said that three of five patients in the study (in one of the dosing cohorts: the 6 mg/kg bexmarilimab + azacitidine doublet) had objective responses.
Meanwhile, eight of 15 objective responses were observed in all three doublet dosing cohorts.
One patient has now stayed on the treatment for 13 months, the company noted.
"The data indicates bexmarilimab has the strong potential to tackle an unmet medical need,” said Dr Marie-Louise Fjällskog, Faron's chief medical officer.
Additionally, Faron added that updated data from the study data supports an advancement to Phase II, in the second half of this year, and said this will focus on ‘SoC relapsed/refractory AML and MDS patients failing hypomethylating agents (HMA)’.
Looking further down the timeline, Faron said that it expects to file the first Biologics License Application (BLA) to US Food and Drug Administration (FDA) planned by the first half of 2025.
"We are extremely encouraged by the continued efficacy signals of bexmarilimab and the long duration of the responses seen so far," said Dr Mika Kontro, principal investigator in the trial and associate professor at Helsinki University Hospital Comprehensive Cancer Center.
"Our goal is to offer a unique hope for patients with no other treatment options in this late stage of AML and MDS."
Faron’s Fjällskog, meanwhile, added: "We're excited to advance bexmarilimab as a leading agent in the fight against cancer and look forward to generating further supporting data ahead of an anticipated BLA filing in H1 2025."