Entera Bio (Nasdaq: ENTX) presented full single-tablet EB613 results on June 14 at ENDO 2026 in Chicago as a late-breaking oral. The single-tablet EB613 achieved a comparable pharmacokinetic and pharmacodynamic profile to Forteo (injectable teriparatide) and to the multi-tablet EB613 used in Entera's earlier Phase 2 study in postmenopausal women with osteoporosis. On the administration-experience quality-of-life questionnaire, 14 of 15 study participants preferred the single tablet to the multi-tablet format, and all 15 preferred the daily oral EB613 to the daily injection. Entera plans to advance the single-tablet formulation into the Phase 3 trial in 750 postmenopausal women starting late 2026, with topline expected H2 2028.
Entera Bio (Nasdaq: ENTX) confirmed that its first-in-class oral PTH(1-34) tablet EB613 was selected for a late-breaking oral presentation at ENDO 2026 covering single-tablet data ahead of the 750-patient Phase 3 trial set to start late 2026 in postmenopausal osteoporosis. EB613 applies Entera's N-Tab oral-peptide delivery platform to teriparatide (the active ingredient in Forteo). On the obesity side, Entera will present preclinical PK/PD data on EB618, a first-in-class oral dual GLP-1/glucagon receptor agonist, in non-human primates on Saturday June 13 12:15-1:45 PM CT. The ENDO slot extends Entera's spring narrative beyond the Q1 2026 Phase 3 plan first disclosed in May.
Entera Bio reported Q1 2026 May 8 with $20.4M cash and an updated Phase 3 plan for EB613, an oral once-daily PTH(1-34) tablet that would be the first oral osteoanabolic for postmenopausal osteoporosis. The streamlined Phase 3 protocol — submitted to the FDA in March — covers 750 postmenopausal women with primary endpoint of total hip BMD change from baseline at month 12. Trial initiation is targeted for late 2026, with topline H2 2028 — roughly one year earlier than previously guided. The molecule applies Entera's N-Tab oral peptide platform to teriparatide, the active ingredient in Forteo. The Phase 2 dose-ranging study in 161 patients met primary (PD/bone-turnover biomarker) and secondary (BMD) endpoints.