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news.Insmed has received approval from the UK's Medicines and Healthcare products Regulatory Agency to initiate the company's first clinical study for a follow-on biologic product candidate.
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Insmed’s INS-19, which is a recombinant form of human G-CSF, is a follow-on biologic of the FDA-approved product Neupogen. Preclinical studies demonstrate that INS-19 and FDA-approved Neupogen are comparable in both their pharmacological and toxicological profile. Detailed analytical characterization also demonstrates that the products have a high degree of similarity.
Data from these initial evaluations have been used, in part, to support the Phase I study, which will be initiated immediately. The Phase I study will be conducted in the UK and will compare the safety and establish the bioequivalence of INS-19 to Neupogen. Results from the trial are expected in the second half of 2008, and are planned to be used as part of a submission to the FDA to establish a protocol with the agency for a Phase III trial in the US.
The initiation of this follow-on biologic trial is the first of two planned for 2008 as part of Insmed’s development of a portfolio of follow-on biologic products.