By M. Marin
READ THE FULL ORMP RESEARCH REPORT
ORA-D-013-1 enrollment surpassed targeted participation…
Oramed Pharmaceuticals Inc. (NASDAQ:ORMP) has multiple clinical development programs underway. ORMD-0801, ORMP's lead development candidate, is being tested in diabetes and NASH. In dual concurrent Phase 3 studies of ORMD-0801 for the treatment of T2D, enrollments for ORA-D-013-1 were exceeded and ORA-D-013-2 is about 50% enrolled. ORMP anticipates topline results from the ORA-D-013-1 trial in Jan. 2023 after the last patient's six months of treatment. We believe topline results from the ORA-D-013-1 trial and NASH study, depending on the results, could be a catalyst for the shares.
We also believe Oramed's multiple clinical development programs underscore the potential versatility of the company's oral protein delivery platform technology. The company believes that ORMD-0801 could become the first commercial oral insulin capsule for the treatment of diabetes. In addition, the oral COVID-19 vaccine (via the Oravax JV) has demonstrated efficacy in pre-clinical studies and is being studied in a Phase 1 clinical trial in South Africa.
The addressable market for diabetes treatment appears to be sizable. The American Diabetes Association (ADA) estimates that in the U.S., roughly 34.2 million people, or 10.5% of the national population, suffer from diabetes (2018 data). The ADA estimates the total cost of diagnosed diabetes in the U.S. aggregates to $327 billion per annum (2017 data) and that people with diagnosed diabetes incur average medical expenditures roughly 2.3x higher than expenditures without diabetes.
ORA-D-013-1 data expected in Jan. 2023; NASH data expected in 3Q22
Oramed is also studying ORMD-0801 for the treatment of NASH (nonalcoholic steatohepatitis). Enrollment has been completed and the company anticipates having topline results to announce in 3Q22. The study is testing ORMD-0801's ability to reduce liver fat, inflammation, and fibrosis in NASH patients. NASH is inflammation and damage to the liver reflecting a buildup of fat. It can be severe and put patients at higher risk to develop cirrhosis, liver failure and hepatocellular carcinoma.
Oral COVID-19 vaccine being studied in Phase 1 clinical trial
The company also continues to advance its JV (joint venture) in the COVID-19 vaccine space for the Oravax oral vaccine. The vaccine has demonstrated efficacy in pre-clinical studies and Oravax is currently conducting a Phase 1 clinical trial of the Oravax VLP COVID-19 vaccine in South Africa.
We believe the multiple studies currently being conducted underscore the potential versatility of the company's oral protein delivery platform technology. Oramed potentially has expanded its potential addressable commercial market into COVID-19 and potentially other viruses and has also expanded the technology behind its oral delivery platform, reflecting the potential versatility of the technology.
Separately, as it continues to advance its T2D studies, the company has also expanded its Scientific Advisory Board with the recent appointment of Dr. Anne Peters to the board. Dr. Peters has substantial experience in diabetes research.
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