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Entera Bio Ltd. (NASDAQ:ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and therapeutic proteins, reported today interim data from an ongoing Phase 1 study designed to assess and compare the pharmacokinetic (PK) and early pharmacodynamic (PD) profile of current and several next generation compositions of its oral peptide platform (NCT05965167).
EB613 Continues to Display an Optimal Profile as First-in-Class Oral PTH(1-34) Peptide for Osteoporosis
The Phase 1 study first compared the PK profile of Entera's Phase 3 candidate, oral once-daily PTH(1-34) mini-tablets (EB613, a.k.a. EBP05 formulation) with subcutaneous (SC) PTH(1-34) 20 g (Forteo®). Consistent with previously reported PK and bioavailability data, EBP05 induced a rapid and dose-proportional increase in plasma drug concentrations of PTH(1-34) at all doses tested. The target bioavailability of PTH (1-34) 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 (p<0.05) effects across all early PD markers such as plasma levels of endogenous PTH(1-84), serum calcium, phosphorus, and 1,25-dihydroxyvitamin D.
"EB613's reproducible PK profile across all our clinical studies, irrespective of age and gender, demonstrates the superiority of our platform to consistently deliver oral peptides in a small and convenient tablet form. Although the amino acid sequence in our oral PTH(1-34) is identical to commercially available injectable teriparatide, there is a clear difference in the exposure profile. EB613 appears to produce a shorter duration of osteoblast and osteoclast activation, which is essential for osteoporosis treatment. EB613 induces the "pulsatile" exposure required to simultaneously stimulate bone formation (anabolic) with a mild anti-resorptive property, as compared to Forteo®. This exciting mechanism is consistent with the primary endpoint, bone turnover data reported from our placebo-controlled Phase 2 study in post-menopausal women at high risk of osteoporosis and potentially, the reason we see more rapid BMD increases at 6 months of treatment with EB613, especially at the total hip and proximal femur sites," said Miranda Toledano, Chief Executive Officer of Entera.
Next Generation Platform Demonstrates Robust Bioavailability with Novel Oral Peptide Compositions
The Phase 1 PK study also assessed novel compositions comprising PTH(1-34) as a model peptide to test Entera's proprietary, next generation platform.
The new compositions show enhanced bioavailability (BA) 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(1-84).
Entera expects to unveil additional data at an upcoming conference.
Posted In: ENTX
