Entera Bio announces interim data from Phase 1 study of oral peptide platform

Entera Bio reported interim data from an ongoing Phase 1 study designed to assess and compare the pharmacokinetic and early pharmacodynamics profile of current and several next generation compositions of its oral peptide platform. EB613 Continues to Display an Optimal Profile as First-in-Class Oral PTH Peptide for Osteoporosis: The Phase 1 study first compared the PK profile of Entera’s Phase 3 candidate, oral once-daily PTH mini-tablets with subcutaneous PTH 20 g. Consistent with previously reported PK and bioavailability data, EBP05 induced a rapid and dose-proportional increase in plasma drug concentrations of PTH at all doses tested. The target bioavailability of PTH with EB613 at doses of 1.5 mg and 2.5 mg, covering the dose range planned for phase 3 was met. Additionally, EB613 exhibited consistent and statistically significant effects across all early PD markers such as plasma levels of endogenous PTH, serum calcium, phosphorus, and 1,25-dihydroxyvitamin D. Next Generation Platform Demonstrates Robust Bioavailability with Novel Oral Peptide Compositions: The Phase 1 PK study also assessed novel compositions comprising PTH as a model peptide to test Entera’s proprietary, next generation platform. The new compositions show enhanced bioavailability versus our first-generation platform, as expected from pre-clinical data. All formulations demonstrated a consistent PK profile to EBP05 with rapid absorption and elimination; and induced fast PD responses increasing calcium, vitamin D levels along with reducing phosphate and endogenous PTH.