Oramed Pharmaceuticals (NSDQ:ORMP) announced today that it reached over 50% enrollment in a trial for its oral insulin treatment.
New York-based Oramed’s Phase 2 trial evaluates its oral insulin capsule ORMD-0801 for the treatment of non-alcoholic steatohepatitis (NASH), with patients continuing to be screened at sites in the U.S. and Israel, according to a news release.
The double-blind, multi-center trial assesses the safety and potential efficacy of the drug in type 2 diabetes patients with NASH, with efficacy endpoints including percentage change in liver fat content, liver fibrosis and liver steatosis from baseline to be measured via MRI-PDFF following 12 weeks of dosing.
Oramed develops a novel protein oral delivery (POD) technology with an eye on transforming diabetes treatment through ORMD-0801, which it says has the potential to be the first commercial oral insulin capsule for treating diabetes.
“With more than half of NASH patients having diabetes, ORMD-0801 has the potential to improve outcomes for patients in both conditions,” Oramed CEO Nadav Kidron said in the release. “NASH is a disease with a significant unmet medical need, as no drugs are currently approved to treat this condition, which is a leading cause of liver transplants in the U.S.
“We are excited to build upon our pilot study’s results which showed a reduction in liver fat content to demonstrate the potential for ORMD-0801 to help patients living with NASH.”