Entera Bio Announces Key Regulatory Milestone for Oral PTH(1-34) Peptide (EB613) Phase 3 Program: FDA Ruling on Qualifying BMD as a Surrogate Endpoint for Osteoporosis Drugs is Expected Within 10 Months
The proposed registrational Phase 3 study for EB613, Entera’s lead clinical candidate, which is a first-in-class PTH(1-34) daily tablet treatment for osteoporosis is designed to meet the quantitative BMD thresholds proposed by SABRE.
- The proposed registrational Phase 3 study for EB613, Entera’s lead clinical candidate, which is a first-in-class PTH(1-34) daily tablet treatment for osteoporosis is designed to meet the quantitative BMD thresholds proposed by SABRE.
- In November 2023 we issued a press release echoing ASBMR’s announcement that SABRE had submitted its final qualification package to FDA for the replacement of fracture as a regulatory endpoint.
- Today we are thrilled to echo ASBMR’s announcement that FDA has set a concrete timetable to issue its ruling.
- Fractures, particularly of the hip, are considered the most serious consequence of osteoporosis, which predominantly affects postmenopausal women and older men.