Faron Pharmaceuticals Limited (AIM:FARN) has identified the final patient for its BEXMAB Phase II study, which is testing a new cancer treatment for a condition called myelodysplastic syndrome (MDS).
In an update, the company said it expects to report early results on the drug’s effectiveness and safety in April 2025, with more detailed findings to be shared at medical conferences later in the year.
MDS is a type of blood cancer that affects bone marrow and can progress to leukaemia. The trial focuses on two groups of patients: those whose cancer has returned or has not responded to previous treatments (refractory or relapsed MDS) and those newly diagnosed with a high-risk form of the disease.
The study will assess around 35 patients with refractory or relapsed MDS and 20 patients with high-risk MDS. Most patients in the first group will receive either a 3mg/kg or 6mg/kg dose of bexmarilimab, an experimental drug, following guidance from the U.S. Food and Drug Administration. A smaller number were treated with a lower 1mg/kg dose during an earlier phase of the study.
Dr Petri Bono, Faron’s Chief Medical Officer, said: “Achieving this milestone for our lead programme, BEXMAB, in r/r MDS and frontline HR MDS, reflects not only our team's strength in executing on the company's drug development strategy but also the urgent unmet medical need for patients with this difficult to treat cancer.”
Results from a previous study, presented in December, reported an 80% positive response rate, significantly higher than the 0-20% seen with current treatment options. Faron is considering expanding patient recruitment to strengthen the data needed for regulatory approval.
"We are committed to rapidly advancing bexmarilimab through clinical development, to bring it to treatment-resistant MDS patients as soon as possible," said Dr Juho Jalkanen, Faron's CEO.
"I want to express my sincere gratitude to all the stakeholders working on the BEXMAB trial, especially our hardworking employees, study site professionals and investigators, but most of all the patients and their loved ones."