Date: 2016-05-09
Type of information: Results
phase: 1
Announcement: results
Company: Pfenex (USA - CA)
Product: PF708 (biosimilar teriparatide)
Action
mechanism: biosimilar/peptide
Disease: osteoporosis
Therapeutic area: Bone diseases
Country: USA
Trial
details: The purpose of this phase 1 study is to compare the pharmacokinetics (blood levels) of two teriparatide products, PF708 and Forteo, in healthy subjects. (NCT02656810)
Latest
news: * On May 9, 2016, Pfenex, a clinical-stage biotechnology company engaged in the development of biosimilar therapeutics, including high value and difficult to manufacture proteins, has reported positive top-line bioequivalence data for PF708. The bioequivalence study in healthy subjects for PF708, a 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 program will include an immunogenicity/pharmacokinetic study in subjects with osteoporosis and is anticipated to initiate by the end of 2016.
