Faron Pharmaceuticals Limited (AIM:FARN) has reported a sharp rise in the number of patients with a high-risk blood disorder achieving full remission following treatment with its experimental drug, bexmarilimab, in combination with standard therapy.
The Finnish drug developer said complete remission, defined as the return of normal blood and bone marrow function, had increased to 43% in newly diagnosed patients with high-risk myelodysplastic syndrome (HR-MDS), up from 28% in earlier data.
The figures come from an updated readout of the company’s ongoing phase I/II trial, known as BEXMAB.
The data were gathered in preparation for an end-of-phase II meeting with the US Food and Drug Administration, a key milestone for any company seeking approval to move into the final stage of clinical testing.
HR-MDS is a serious and fast-progressing blood cancer where the bone marrow fails to produce healthy blood cells.
Patients in the trial were treated with a combination of bexmarilimab and azacitidine, a widely used chemotherapy drug, and were assessed using the 2006 criteria of the International Working Group, which are standard in this field.
Faron’s latest results suggest that responses to the treatment have deepened over time, with more patients moving from partial remission to complete remission.
The company had already reported a 50% composite complete remission rate, a broader measure that includes both complete and near-complete responses, and said the new data showed that many of those responses are maturing into full remissions.
That compares favourably with the 16–17% remission rate typically seen in patients treated with azacitidine alone.
Petri Bono, Faron’s chief medical officer, said: “Seeing the CR rate strengthen over time to 43%, which complements the robust 50% cCR we have already reported, is very encouraging.
"It provides us with two compelling and clinically meaningful data sets for discussion with the FDA and gives us confidence in proposing a randomised registrational trial designed for accelerated approval with either CR or cCR as the primary endpoint.”