Entera Bio reports Phase 1 data of oral PTH peptide candidate at ENDO 2024

Entera Bio announced Phase 1 clinical data for its hypoparathyroidism focused investigational program, EB612, as presented on June 1st at the Endocrine Society ENDO 2024 Annual Meeting. Entera’s EB612 program aims to provide the first oral PTH daily tablet hormone replacement therapy for patients suffering from hypoparathyroidism. Late stage investigational PTH replacement treatments include TransCon PTH by Ascendis Pharma A/S and eneboparatide by Amolyt Pharma. Both these modalities require patients to administer injections every day. Entera previously published positive Phase 2a study results in hypoparathyroid patients with four times a day regimen of EB612. The data reported from this Phase 1 clinical study include pharmacokinetic, pharmacodynamic and safety results from the application of a new generation of Entera’s N-Tab technology platform and EB612, the active peptide fragment 1-34 of the N-terminal region of human parathyroid hormone dosed twice a day. Significant systemic exposure was reported following both administrations of EB612 tablets. Aside from positive PK measures, sustainable PD effects were reported, including serum levels of calcium, phosphate, and 1,252-Vitamin D and decreased endogenous serum PTH. There were no treatment-emergent Adverse Events of hypercalcemia reported. There were no treatment-emergent Serious AEs. The only Study Drug-Related AE was mild headache, reported in two out of fifteen subjects. No significant findings were observed in blood and urine lab tests. All vital signs were within the normal range. “The encouraging findings from this Phase 1 study reaffirm the ability of our N-Tab(TM) platform to develop simple oral tablet treatments of important peptide therapeutics. Here we suggest that a BID administration of our unmodified PTH peptide may provide a viable alternative for patients with hypoparathyroidism who require a peptide replacement therapy for life and are intolerant, adverse or cannot access a daily injectable product,” said Miranda Toledano, Chief Executive Officer at Entera.