Oramed Pharmaceuticals Inc. ( Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, announced today positive Phase 2 results from its double-blind, fully randomized, placebo-controlled, multicenter trial to assess the safety and efficacy of its oral insulin candidate (ORMD-0801), to reduce liver fat content in Type 2 Diabetes (“T2D“) patients with non-alcoholic steatohepatitis (“NASH“).
The 12-week trial enrolled 32 patients (with 30 patients completing) and demonstrated that ORMD-0801 was safe and well tolerated at 8 mg twice daily dosing, meeting the primary endpoint of no difference in adverse events for ORMD-0801 compared to placebo.
The trial also evaluated the effectiveness of ORMD-0801 in reducing liver fat content over the 12-week treatment period by observing several independent measures. These measurements included MR PDFF(%) as measured by MRI, Steatosis and Fibrosis as measured by Fibroscan, Lipids and HbA1c. All the measurements showed a consistent clinically meaningful trend in favor of ORMD-0801.
“These results paint an exciting picture for the potential of our oral insulin candidate to treat patients with both diabetes and NASH, a very serious condition with few treatment options,” said Oramed‘s Chief Executive Officer, Nadav Kidron. “At the same time, we await the top-line data from our Phase 3 trial of oral insulin for T2D, which we expect in January 2023.”
The company now awaits top-line readouts from two pivotal phase 3 trials assessing ORMD-0801, one of which is anticipated for January 2023, according to Kidron.
In addition to its lead candidate ORMD-0801, Oramed is also developing an oral GLP-1 analog capsule called ORMD-0901 that is in a phase 1 trial for diabetes.
The NASH landscape is a bleak one, with several big names hitting roadblocks in recent months. In July, Pfizer dumped its early-stage asset danuglipron, a GLP-1 agonist also known as PF-06882961.
Meanwhile, Novo Nordisk has been working to bring semaglutide—the GLP-1 molecule behind the company’s leading marketed trio of Ozempic, Rybelsus and Wegovy—into the world of NASH. However, the Danish big pharma revealed in June that the drug failed to match placebo in a phase 2 study. Nevertheless, the company stands behind it, awaiting results from a separate phase 3 trial targeting NASH patients who’ve already advanced beyond the disease’s non-fibrotic stages.
About the Trial
ORA-D-N02 is a Phase 2 double-blind, randomized, placebo-controlled, multicenter trial to assess the safety and efficacy of Oramed’s oral insulin candidate, ORMD-0801, to reduce liver fat content in T2D patients with NASH. The trial’s primary endpoint was to evaluate the safety of oral insulin in patients with NASH and T2D, with a secondary endpoint to assess, non-statistically, ORMD-0801‘s efficacy in reducing liver fat content in patients with NASH and T2D.
The trial recruited 32 patients who were administered either placebo (11 patients) or ORMD-0801 8 mg twice daily (one capsule in the morning, prior to breakfast, and one capsule at night) (21 patients) for 12 weeks.
NASH is a serious, progressive liver disease caused by a buildup of fat in the liver and accompanied by inflammation, liver cell damage, and in some cases, scarring of the liver. Over time, NASH may progress to cirrhosis, liver cancer, liver failure, and even death. Currently, no pharmacotherapy is globally approved for the treatment of NASH, and people with NASH are left with very few treatment options.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals (Nasdaq/TASE: ORMP) is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, with offices in the United States and Israel, Oramed has developed a novel Protein Oral Delivery (POD™) technology. Oramed is seeking to transform the treatment of diabetes through its proprietary lead candidate, ORMD-0801, which is being evaluated in two pivotal Phase 3 studies and has the potential to be the first commercial oral insulin capsule for the treatment of diabetes. In addition, Oramed is developing an oral GLP-1 (Glucagon-like peptide-1) analog capsule (ORMD-0901).
For more information, please visit Oramed www.oramed.com
Zach Herschfus Tel +1-844-9-ORAMED zach AT oramed.com
Source: Cision PRnewswire Sep 13, 2022
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