Clinical-stage pharmaceutical company Oramed Pharmaceuticals Inc. (ORMP:NASDAQ), which focuses developing oral delivery solutions for drugs currently delivered via injection, yesterday announced that "it has screened the first patients in a global trial of its oral insulin capsule ORMD-0801 for the treatment of nonalcoholic steatohepatitis (NASH)." The company stated that the Phase 2 NASH Oral Insulin Trial is being conducted at clinical sites in the U.S., EU and Israel and that all of the patient participants were first prescreened at its U.S. clinical site.
The official name of the study is "A Study of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients With Nonalcoholic Steatohepatitis (NASH)." The firm explained that the goal of the clinical study is to measure efficacy endpoints via MRI-PDFF for 12-weeks dosing at eight separate locations including three each in the U.S. and EU and two additional sites in Israel.
Oramed Pharmaceuticals' CEO Nadav Kidron commented, "Based on the strong results from our previous study, where ORMD-0801 showed a 30% relative reduction in liver fat, we are excited to be starting this important international NASH trial and we look forward to sharing the data as it becomes available."
Oramed Pharmaceuticals is headquartered in New York and also has offices in Israel. The firm described its business as "a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection." Oramed advised that it has created and engineered a new protein oral delivery (POD™) technology.
The company indicated that its proprietary lead candidate ORMD-0801 offers the potential to be the first commercial oral insulin capsule for the treatment of diabetes. The company believes this would be transformative compared to the currently available injection-based delivery systems. Oramed added that it has previously completed several Phase 2 clinical studies of ORMD-0801 under an Investigational New Drug application with the U.S. Food and Drug Administration.
In addition, Oramed is developing an oral GLP-1 (Glucagon-like peptide-1) analog capsule, ORMD-0901, for treatment of type 2 diabetes (T2DM).
Oramed Pharmaceuticals started the day with a market capitalization of around $92.3 million approximately 23.68 million shares outstanding. ORMP shares opened a little more than 2% higher today at $3.99 (+$0.09, +2.31%) over yesterday's $3.90 closing price. The stock has traded today between $3.99 and $4.81 per share and is currently trading at $4.36 (+$0.46, +11.79%).
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