Entera Bio has announced that post‑hoc findings from its phase 2 trial of EB613, an oral PTH(1‑34) tablet, have been chosen for two presentations at the ASBMR 2026 annual meeting in Boston. The data include a plenary poster, one of the highest‑ranked categories selected by the ASBMR committee.
EB613 is in development as the first oral anabolic tablet for osteoporosis. The phase 2 study enrolled 161 postmenopausal women with low bone mass or osteoporosis and randomised them to placebo or four EB613 dose levels for 6 months.
Entera plans a single, randomised, double‑blind, placebo‑controlled phase 3 trial involving around 750 postmenopausal women to support a potential New Drug Application. A post‑hoc sensitivity analysis examined how baseline T‑score severity influenced EB613’s effects on bone mineral density and bone turnover markers at 6 months.
Tripto‑Shkolnik explained: “EB613 produced rapid dose‑proportional increases in biochemical markers of bone formation and reductions in markers of bone resorption.”
He added: “The effects on trabecular and cortical bone suggest that bone strengthening and fracture resistance may occur rapidly with EB613.”
The company noted that EB613 increased lumbar spine, total hip and femoral neck BMD, with 3D‑DXA analysis showing improvements in integral volumetric BMD, trabecular volumetric BMD, cortical thickness and cortical surface BMD.
Osteoporosis remains a major public health challenge, causing over 2 million fractures annually in the US. One in three women and one in five men over 50 will experience an osteoporosis‑related fracture, with hip fractures associated with up to 24% mortality within a year.
Postmenopausal women are at particular risk due to oestrogen deficiency, which accelerates bone loss in the first decade after menopause. Existing anabolic therapies are administered by subcutaneous injection, limiting their use among eligible patients.
Forteo was approved by the FDA in 2002 for postmenopausal osteoporosis and later for men at high fracture risk and for glucocorticoid‑associated osteoporosis.
