Faron Pharmaceuticals Ltd
This Phase IIb study (BEXERA) will evaluate the safety and efficacy of bexmarilimab (FP-1305), an antibody targeting Clever-1, given in combination with azacitidine compared with azacitidine plus placebo in adults with treatment-naïve higher-risk myelodysplastic syndromes (HR-MDS). Participants will be randomized to receive bexmarilimab at one of two dose levels (1 mg/kg or 3 mg/kg) plus azacitidine, or placebo plus azacitidine. The primary aim is to select the recommended dose of bexmarilimab for subsequent development based on a predefined integration of clinical response and safety/tolerability.
Inclusion Criteria: 1. Participant provides written informed consent. 2. Participant is ≥18 years of age. 3. Participant has newly diagnosed MDS with morphologically confirmed HR-MDS as defined according to 2022 World Health Organization classification (5th Edition, Annex 7). 1. IPSS-M classification of moderately high risk, high risk, and very high risk. 2. \<20% bone marrow blasts per bone marrow biopsy/aspirate at screening 4. Participant is eligible for azacitidine per local practice and willing to initiate trial therapy. 5. Participant has ECOG performance score 0 to 2. 6. Partici…
1mg/kg. Administered weekly (Q1W) with the opportunity to reduce frequency to biweekly (Q2W) based on time on treatment and disease response. Intravenous (IV) administration
Standard of care medication, administered per institutional guidelines/label
Participants will receive saline placebo, prepared by the local site pharmacy to match bexmarilimab at point of dispensation. Administered on a schedule to match bexmarilimab
3mg/kg. Administered weekly (Q1W) with the opportunity to reduce frequency to biweekly (Q2W) based on time on treatment and disease response. Intravenous (IV) administration