Press release
Oramed Provides Clinical Update with Meaningful Data Expected by Year-End
Completed recruitment and randomization of all patients in the primary cohort of Phase IIb HbA1c trial for oral insulin capsule ORMD-0801, potentially the
About this update from Oramed Pharmaceuticals Inc.
[{"type":"text","content":"Completed recruitment and randomization of all patients in the primary cohort of Phase IIb HbA1c trial for oral insulin capsule ORMD-0801, potentially the first commercial oral insulin capsule for the treatment of Type 2 diabetes; results expected in 4Q 2019; following results Oramed plans to initiate end of Phase II meeting with FDA to plan for Phase III Initiated second low dose cohort in Phase IIb HbA1c trial for oral insulin capsule ORMD-0801 to evaluate potential efficacy of lower doses; results expected in 1Q 2020 Evaluating results of Phase I PK study of oral GLP–1 analog ORMD-0901 to assess options for supplemental studies Examination of ORMD-0801 underway for the treatment of nonalcoholic steatohepatitis (NASH) patients Clinical trial for oral leptin capsule for weight loss initiated NEW YORK, June 18, 2019 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, today provided a clinical update regarding four ongoing clinical programs.\n\n \n\"All of our clinical programs continue to advance on-track as planned with no related serious adverse safety issues. We expect to provide meaningful clinical results from these ongoing trials in the coming months,\" stated Oramed CEO, Nadav Kidron. \"We believe we have a unique oral technology platform that has the potential to revolutionize the effective delivery of important medication to improve treatment of diabetes and related conditions.\" \nOral Insulin: \nIn mid-May, Oramed completed enrollment and randomization of close to 300 patients in the primary cohort for its 90-day dose-ranging Phase IIb HbA1c clinical study of its oral insulin capsule, ORMD-0801, for Type 2 diabetes.\nOver 80% (237 patients) of these patients have completed treatment in the study. \nThe Phase IIb double-blind, randomized study for Type 2 diabetes is designed to identify the optimal dose to take into Phase III evaluation. The Phase IIb study will assess the primary efficacy endpoint of reduction in HbA1c as well as safety endpoints. Study results for the primary cohort are expected by year-end 2019. Following the results of the primary cohort Oramed plans to initiate an end of Phase II meeting with the FDA to discuss Phase III protocol. \nIn addition, Oramed initiated a secondary cohort...