Cinfa Biotech treats first subjects in pegfilgrastim biosimilar clinical trial
Cinfa Biotech S.L., the biosimilars company of Infarco group, today announced that the first subjects have been dosed in a clinical trial of B12019, a biosimilar version of Neulasta(R) (pegfilgrastim) to treat chemotherapy-induced neutropenia. B12019 is a pegylated granulocyte colony-stimulating factor (G-CSF) receptor agonist, which is used to stimulate bone marrow to produce more neutrophils to decrease the incidence of infections in patients undergoing chemotherapy.
B12019, the lead development program of Cinfa Biotech, has completed preclinical studies, and the manufacturing process (GMP) for B12019 has been implemented at commercial scale. This trial is the first part of a clinical development program investigating the clinical comparability of B12019, which has been designed based on the longstanding expertise of Cinfa Biotech’s team in developing biosimilars.
The single dose, cross-over study will enrol up to 170 healthy volunteers in Germany. It primarily investigates the pharmacokinetics (PK) and the pharmacodynamics (PD) of B12019 as compared to Neulasta(R). The study design is based on scientific advice from the European Medicines Agency (EMA) and is tailored to the specific properties of pegfilgrastim.