Entera Bio Stock Skyrockets On Positive EB613 Biomarker Analysis Data In Osteoporosis Study

Entera Bio Ltd (NASDAQ: ENTX) is soaring in the premarket in reaction to positive topline data from the Phase 2 trial of EB613 in postmenopausal female subjects with osteoporosis (low bone mineral density).

• Three-month bone biomarker data analysis showed a significant increase in the P1NP biomarker in the 2.5 mg dose group after three months of treatment compared to placebo.
• P1NP is a biomarker that indicates the rate of new bone formation and the change at three-months (primary endpoint in this Phase 2 trial.
• On the secondary endpoints, a significant increase in Osteocalcin (a biomarker for bone formation) was also observed in the EB613 2.5 mg group after three months.
• A significant decrease in CTX (indicative of bone mass) was observed in line with a potential anabolic effect after three months of treatment.
• All the effects taken together indicate a potentially positive impact on bone mineral density and a reduced risk of fractures, which is the goal of anabolic osteoporosis treatment.
• EB613 was generally well tolerated through three months of treatment.
• The interim analysis of the three-month data from the first 50% (n=80) of subjects randomized demonstrated a significant increase in P1NP after one month of treatment at the 1.5 mg dose compared to placebo.
• EB613 is an orally delivered human parathyroid hormone (1-34), or PTH, drug candidate positioned as the bone-building (anabolic) treatment for osteoporosis patients.
• Entera Bio completed enrollment of a 6-month Phase 2 study evaluating multiple doses of oral EB613 (and placebo) on BMD of the spine and proximal femur (hip). Topline efficacy and safety results anticipated in the second quarter of 2021.
• Price Action: ENTX shares jumped 179.4% at $4.49 in premarket trading on the last check Thursday.