Entera Bio’s osteoporosis candidate for postmenopausal women showed statistically significant improvements in bone density in a Phase II trial.
Presented at the 2025 North American Menopause Society (NAMS) Annual Meeting, new analysis showed that 2.5mg EB613 produced significant and consistent gains in bone mineral density, supporting the dose selection for the upcoming Phase III trial.
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In the study (NCT04003467), EB613 increased bone density in the lumbar spine, hip and femoral neck in early postmenopausal women after six months.
Density in the lumbar spine increased by 3.1% compared to placebo, which Entera states to be a “key fracture site”. In the hip, a 2.3% increase in bone strength was seen and in the femoral neck, a 2.0% increase was reported, both compared to placebo.
After the data was announced, the company’s stock initially rose, from a $2.30 close on 22 October to a $2.41 open on 23 October, however this dropped during the day, closing at $2.14. Entera Bio has a market cap of $97.72m.
Dr Steven Goldstein, professor of obstetrics and gynaecology at NYU School of Medicine and member of Entera’s Clinical and Scientific Advisory Board, said: “What’s particularly significant is the consistency of response across different stages of menopause.
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By GlobalData“The fact that we’re seeing these results with an oral formulation addresses one of the most significant barriers in osteoporosis care, opening the door to introduce anabolic therapy earlier in the treatment journey, when injectable options are rarely used. This could be a gamechanger for patient access and compliance.”
This data is similar to that seen in a study of the drug in improving bone density in women more than ten years post-menopause, in which EB613 increased femoral neck strength by 3.2% and lumbar spine strength by 2.5%.
EB613, a once-daily oral PTH (1-34) anabolic tablet, is being developed as the first oral bone-building therapy for postmenopausal women at high risk for fracture. Anabolic therapies are currently administered by subcutaneous injection and used in a minority of eligible patients.
GlobalData analyst Sulayman Patel agrees that anabolics will continue to play a key role in osteoporosis treatment.
Patel said: “Anabolic therapies stimulate bone formation and play a crucial role in osteoporosis. Despite their higher cost over traditional bisphosphonates, their effectiveness in enhancing bone density justifies their increasing adoption.”
A GlobalData report predicts that the osteoporosis market is set to grow from $10.5bn in 2023 to $17.9bn in 2033 in the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK and Japan).
GlobalData is the parent company of Clinical Trials Arena.
