$ENTX Entera Bio Ltd Announces Positive Topline EB613 Phase 2
Entera Bio Ltd Announces 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
‒ 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.
‒ Similar to the increase in P1NP, a significant increase in Osteocalcin was also observed in the 2.5 mg group after 3 months (P <0.01).
‒ In line with a potential anabolic effect, a significant decrease in CTX was observed after 3 months of treatment (P <0.015). The decrease in CTX taken together with the increase in P1NP and Osteocalcin would indicate a potential positive impact on BMDand a reduced risk of fractures, which is the goal of an anabolic osteoporosis treatment.
‒ Entera intends to submit the full dataset for publication and/or presentation at an upcoming medical conference.
‒ 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
‒ 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.
‒ Similar to the increase in P1NP, a significant increase in Osteocalcin was also observed in the 2.5 mg group after 3 months (P <0.01).
‒ In line with a potential anabolic effect, a significant decrease in CTX was observed after 3 months of treatment (P <0.015). The decrease in CTX taken together with the increase in P1NP and Osteocalcin would indicate a potential positive impact on BMDand a reduced risk of fractures, which is the goal of an anabolic osteoporosis treatment.
‒ Entera intends to submit the full dataset for publication and/or presentation at an upcoming medical conference.