Entera Bio announced that The American Society for Bone and Mineral Research, ASBMR, announced on March 25 2024 that the U.S. Food and Drug Administration, FDA, has communicated to the SABRE project team that a ruling to qualify the treatment-related change in bone mineral density as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs would be provided 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.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on ENTX:
- 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
- Entera Bio announces PK data from oral GLP-2 peptide tablet treatment
- Entera Bio management to meet virtually with Oppenheimer
- Entera Bio management to meet with Oppenheimer
- Entera Bio Ltd Shares Financial Update for Investor Awareness