The AIM-listed biotech says the collaboration with the global clinical research organisation marks a key operational milestone ahead of a trial start planned for the second half of 2026.
Faron Pharmaceuticals Limited (AIM:FARN) has appointed Parexel International as its clinical research organisation to run the upcoming BEXERA trial, a mid-stage study testing its lead drug bexmarilimab.
It will be administered to patients with higher-risk myelodysplastic syndromes (HR-MDS), a serious bone marrow disorder in which the body fails to produce enough healthy blood cells.
The BEXERA trial is a randomised, double-blind, placebo-controlled Phase IIb study, meaning neither patients nor investigators will know which treatment is being administered, and results will be compared against a placebo group to assess whether the drug is genuinely working.
The trial will test bexmarilimab at two doses, 1 mg/kg and 3 mg/kg, in combination with azacitidine, the current standard chemotherapy treatment for HR-MDS, against azacitidine alone.
Ninety patients are expected to be enrolled across sites in North America and Europe, with the trial designed to identify the best dose to carry forward into a larger, registration-enabling phase III study that could form the basis of a future regulatory application.
Bexmarilimab works by targeting a protein called Clever-1, found on immune cells known as macrophages, which cancer cells exploit to hide from the body's immune system. By blocking Clever-1, the drug is designed to reprogram the tumour environment and trigger an immune response against the cancer.
Parexel was selected for its track record in haematology (blood cancer) trials and global reach across complex, multinational clinical programmes.
Faron chief medical officer Dr Petri Bono said the partnership represented "a key operational milestone" and described HR-MDS as a condition with high unmet need where new frontline treatment options are urgently required.
Parexel chief medical officer Dr Charlotte Moser said the study represented "an important opportunity to create a novel approach for patients with high-risk MDS, where treatment is difficult to dose and alternative treatment options remain limited."