Oramed Pharmaceuticals Inc (ORMP)

[midastouch017]

Oramed Completes Patient Enrollment in Phase 2 Oral Insulin NASH Trial

https://finance.yahoo.com/news/oramed-completes-patient-enrollment-phase-122500595.html

- Topline results expected H2 2022

- ORMD-0801 is the first oral insulin to be evaluated as a treatment for NASH

- Currently no FDA approved therapy exists for NASH

NEW YORK, March 16, 2022 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP), (TASE: ORMP), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, today announced it has completed enrollment of all patients in a Phase 2 trial of its oral insulin capsule ORMD-0801 for the treatment of non-alcoholic steatohepatitis (NASH). An estimated 1.5% to 6.5% of adults in the U.S., or between 4 million and 17 million people, have NASH and about half of these also have diabetes, according to the National Institute of Diabetes and Digestive and Kidney Diseases.

The double-blind, multi-center trial with clinical sites in the U.S. and Israel is assessing the safety and potential efficacy of ORMD-0801 in Type 2 diabetes patients with NASH. Efficacy endpoints including safety and percentage change in liver fat content, liver fibrosis, and liver steatosis from baseline are measured via MRI-PDFF following 12 weeks of dosing.

"There is currently no drug approved to treat this disease, leaving NASH with a serious unmet medical need. With direct action on the liver, we believe that ORMD-0801 has the potential to address over 50% of people with diabetes who also suffer from NASH, a population with unfortunately increased mortality. We look forward to analyzing and reporting topline data, which we expect will confirm our prior pilot study's efficacy and safety results," said Oramed Chief Executive Officer, Nadav Kidron.

The global market for drugs to treat NASH is expected to reach $84 billion by 2029, according to a publication by Research and Markets on the Global Non-Alcoholic Steatohepatitis (NASH) Drugs Market.