Clinical TrialsEntera Bio achieved alignment with the FDA that a single Phase 3 study with total hip BMD as primary endpoint would support a New Drug Application for a drug to treat post-menopausal osteoporosis.
Product DevelopmentEntera Bio recently announced the presentation of a poster entitled 'A First-in-Class Oral GLP-2 Analog for Treatment of Short Bowel Syndrome' at the 47th European Society for Clinical Nutrition & Metabolism (ESPEN) Congress, highlighting pharmacokinetic (PK) data relating to its oral GLP-2 analog program.
Regulatory ApprovalFDA ratifies surrogate endpoint use in osteoporosis registrational trials, mitigating significant risks for Entera Bio.