Pfenex Inc., a clinical-stage biotechnology company engaged in the development of biosimilar therapeutics, including high value and difficult to manufacture proteins, reported positive top-line bioequivalence data for PF708.
"Today we are excited to announce the positive top-line data from our initial bioequivalence study in healthy subjects for PF708. As we disclosed previously, we are developing PF708 as a therapeutic equivalent to Forteo, through the 505(b)(2) regulatory path in the US. Based on the feedback we have received from FDA, and the positive data announced today, we expect to satisfy the 505(b)(2) filing requirements with an additional immunogenicity/pharmacokinetic study in subjects with osteoporosis," stated Bertrand C. Liang, chief executive officer of Pfenex. "The clinical program is anticipated to initiate by year-end."
The bioequivalence study in healthy subjects for PF708, our peptide product candidate being developed as a therapeutic equivalent to Forteo, met the primary outcome measures. This initial bioequivalence study for PF708 was designed as a double blind, randomized two treatment cross over in 70 healthy adult subjects. Half of the subjects were randomized to receive PF708 first and then Forteo second while the other half was randomized to receive Forteo first and then PF708 second. The primary outcome measures were serum area-under-the-curve (AUC) and serum maximum concentration (Cmax) of PF708 and Forteo. The 90% confidence intervals of the geometric mean ratios for PF708 compared to Forteo, for both AUC and Cmax, fall within the limits of 80%-125%.
In addition to the positive bioequivalence study announced, the pivotal PF708 clinical programme will include an immunogenicity/pharmacokinetic study in subjects with osteoporosis and is anticipated to initiate by the end of 2016. We believe that the clinical program in the US can be leveraged for regulatory filings in other geographies and additional updates will be provided over the course of 2016.