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Investing.com -- Entera Bio Ltd (NASDAQ:ENTX) stock jumped 9.1% in pre-market trading after the FDA agreed that the company’s New Drug Application (NDA) for EB613 could use bone mineral density (BMD) as the primary endpoint in its Phase 3 study, rather than fracture incidence.
The regulatory agreement represents a significant shift from previous requirements for osteoporosis drugs, which typically demanded fracture reduction as the primary endpoint in placebo-controlled Phase 3 studies. Instead, Entera can proceed with a 24-month study measuring change in total hip BMD as the primary endpoint, with vertebral fracture incidence as a secondary endpoint.
This development allows Entera to advance its clinical program without waiting for the FDA’s qualification of the Study to Advance Bone Mineral Density as a Regulatory Endpoint (SABRE), expected later this year.
EB613 is being developed as the first oral, once-daily anabolic tablet treatment for postmenopausal osteoporosis, a condition that affects an estimated 200 million women globally. The company notes that one in two women over age 50 will suffer an osteoporosis-related fracture, highlighting the significant unmet medical need.
According to Entera, no new osteoporosis drug has received FDA approval since 2019, with innovation stalled due to the size, duration, cost, and ethical constraints of fracture endpoint studies. The company’s oral peptide technology aims to provide an alternative to injectable treatments for this widespread condition.
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