‒ Institutional Review Boards (IRBs) Approve Amended Phase 2 Protocol with Newly Enrolled Patients Receiving a 2.5 mg Dose, 1.5 mg Dose, or Placebo ‒
‒ Company Continues to Expect Completion of Enrollment in Q3:20 and Intends to Follow All Patients for Bone Mineral Density and Biomarker (BMD) Data After Six Months of Treatment ‒
‒ Biomarker Data from the Higher Dose Groups Expected in Early Q1:21 with Full Six-month BMD Data Expected in Early Q2:21 ‒
BOSTON and JERUSALEM, July 07, 2020 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered large molecule therapeutics, announced receipt of approval from the IRBs at the clinical sites for the amendment to its Phase 2 protocol to include the testing of higher doses of EB613.
The amendment was submitted after the analysis of the interim Phase 2 biomarker and safety data supported the evaluation of a higher dose of EB613 in the trial. The interim readout demonstrated statistically significant effects on the P1NP biomarker after one month of treatment (p