Entera Presents Phase 1 Data Supporting Single-Tablet EB613 for Osteoporosis at ENDO 2026
Tuesday, June 16, 2026
Entera Bio has presented new Phase 1 clinical data at ENDO 2026 supporting the development of a single-tablet version of EB613, its investigational oral parathyroid hormone (PTH(1-34)) treatment for osteoporosis. The findings were shared during a late-breaking oral presentation at the annual meeting of the Endocrine Society in Chicago.
EB613 is being developed as a once-daily oral anabolic therapy for osteoporosis and could become the first tablet-based treatment in this class. Current anabolic therapies, including Forteo, Tymlos and Evenity, require regular injections, limiting their use among eligible patients.
The Phase 1 study enrolled 15 healthy participants who received single-tablet EB613, multi-tablet EB613 and subcutaneous Forteo at doses ranging from 1 mg to 3 mg. The trial compared the pharmacokinetic and pharmacodynamic profiles of the three treatments.
Results showed that the single-tablet and multi-tablet versions of EB613 produced similar peak concentrations, time to peak concentration and overall systemic exposure. Both oral formulations also demonstrated systemic exposure levels comparable to Forteo, although with a slightly shorter duration of exposure, consistent with previous Phase 1 studies.
The study further showed comparable effects on serum calcium levels and suppression of endogenous PTH(1-84) across both oral EB613 formulations and Forteo. Safety findings were also similar, with no treatment-related serious adverse events reported. All other adverse events were mild and resolved without intervention.
Patient preference data indicated strong support for the simplified dosing approach. Fourteen of the 15 participants preferred the single-tablet formulation over the multi-tablet version, while all participants favoured a daily oral treatment compared with daily injections.
Based on these findings, Entera has selected the single-tablet formulation of EB613 as the final candidate for advancement into a Phase 3 clinical study.
EB613 is an oral form of teriparatide designed to provide the benefits of anabolic osteoporosis therapy without injections. In a previous Phase 2 placebo-controlled study involving 161 women with postmenopausal osteoporosis or low bone mineral density, the treatment met all biomarker and bone mineral density endpoints without significant safety concerns. The study demonstrated improvements in bone formation markers, reductions in bone resorption markers and increases in bone mineral density at the lumbar spine, total hip and femoral neck.
Additional analyses also showed improvements in both trabecular and cortical bone measurements, suggesting that EB613 may help strengthen bone and improve fracture resistance. The results were consistent with outcomes previously reported for injectable teriparatide at the six-month assessment period.
Source: globenewswire.com
