Press release
Oramed Issues Letter to Shareholders with Updates on Oral Insulin and COVID-19 Vaccine
- Phase 3 Studies of Oral Insulin Underway and on Schedule - Oral COVID-19 Vaccine Clinical Trials Through Oravax Medical to Begin H2 2021 NEW YORK, May 25,
About this update from Oramed Pharmaceuticals Inc.
[{"type":"text","content":"- Phase 3 Studies of Oral Insulin Underway and on Schedule\n - Oral COVID-19 Vaccine Clinical Trials Through Oravax Medical to Begin H2 2021\n\n\nNEW YORK, May 25, 2021 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, is pleased to provide the following Letter to Shareholders from Chief Executive Officer Nadav Kidron.\n \n\n \nDear Shareholders,\nI'm excited to share with you significant milestones we have achieved over the past few months. Our oral delivery platform technology could apply to a range of proteins and disease modalities, and we expect over time to have a range of programs. We are currently advancing our two primary programs: oral insulin for diabetes and an oral COVID vaccine. We believe these milestones create an inflection point in the value for our company.\nORMD-0801 Positioned to be the World's First Oral Insulin Capsule \nWe're pleased at the pace of our Phase 3 oral insulin studies. Under a U.S. FDA protocol, we are advancing two concurrent pivotal Phase 3 studies for ORMD-0801 in the treatment of type 2 diabetes (T2D). ORA-D-013-1 has recruited close to 300 of the planned 675 patients through 75 U.S. clinical sites, while ORA-D-013-2 has commenced enrollment. We look forward to keeping you updated on the progress of these studies. \nWe anticipate completing enrollment for the U.S. study, ORA-D-013-1, before the end of 2021 and announcing initial results from this study in 2022. Following results from both studies, we expect to submit a Biologics License Approval (BLA) filing to the FDA. \nUnlocking Value with Oravax Medical \nOral COVID-19 Vaccine Clinical Trial through Oravax Medical to Begin H2 2021 Oravax Expected to Bring Value to Oramed Shareholders, Potentially Through Dividend Shares of Oravax Medical Shares to Oramed ShareholdersOur platform technology for the oral delivery of proteins has the potential to be transformative and is generating a lot of interest in the vaccine industry. Oravax Medical Inc., Oramed's venture that combines Oramed's proprietary POD™ oral delivery technology and Premas Biotech's novel vaccine technology, is preparing to begin clinical trials of an oral COVID-19 vaccine in H2 2021. \nA single dose of Oravax Medical's oral vaccine produc...