The clinical study was a single-center, randomized, double-blind, two-way, crossover bioequivalence design in healthy volunteers. Approximately 32 volunteers enrolled and all completed the study as planned.
Each volunteer received a single dose of either INS-19 or Neupogen, underwent a wash-out period, and returned to the clinic for a single dose of the alternate product. Blood samples were collected to characterize the pharmacokinetic and pharmacodynamic responses to each dose administration.
Results of this clinical study demonstrated bioequivalence between INS-19 and Neupogen. Granulocyte colony stimulating factor (G-CSF) concentration profiles for the two products were identical. Absolute neutrophil count, the primary pharmacodynamic marker for G-CSF products, exhibited the same response profile to dosing with INS-19 as with Neupogen.
These human INS-19 and Neupogen data complement Insmed’s extensive analytical testing and comparative data from preclinical assessments.
Geoffrey Allan, president and CEO of Insmed, said: “These results are very exciting, as they represent Insmed’s ability to replicate a protein product, to bring that product rapidly through the clinic and to demonstrate clear bioequivalence to the innovator drug.”