Entera Bio: Positive Topline EB613 Phase 2 Biomarker Data

 Trial Met Primary Endpoint of Significant Increase in P1NP Based on Final Analysis of 3 Month Data ‒

‒ Final Analysis of 6-Month Data, Including Change in Bone Mineral Density, Expected in Q2:21 ‒

Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered large molecule therapeutics, announced the complete 3-month bone biomarker data analysis from the ongoing Phase 2 clinical trial of EB613. EB613 is an orally delivered human parathyroid hormone (1-34), or PTH, positioned to be the first oral bone building (anabolic) product to treat osteoporosis patients. The Phase 2 clinical trial of EB613 is a 6-month, dose-ranging, placebo-controlled, study in postmenopausal female subjects with osteoporosis, or low bone mineral density (BMD), and is being conducted at four leading medical centers in Israel to evaluate the safety of EB613 and identify the best dose(s) for a potential Phase 3 registration trial.

The trial’s primary endpoint was met - the complete 3-month results from the trial showed a significant increase in the P1NP biomarker in the 2.5 mg dose group after 3 months of treatment (P <0.04) as compared to placebo. P1NP is a biomarker that indicates the rate of new bone formation and the change at 3-months is the primary endpoint in this Phase 2 trial.

https://finance.yahoo.com/news/entera-bio-ltd-announces-positive-133000303.html