Oramed Pharmaceuticals' lead asset, oral insulin ORMD-0801, failed to meet both primary and secondary endpoints in a key phase 3 trial in patients with type 2 diabetes, the company revealed in a brief press release.
The randomized, double-blind, placebo-controlled, multicenter clinical trial (ORA-D-013-1) compared the efficacy of ORMD-0801 to placebo in 710 patients with type 2 diabetes. The trial did not meet its primary endpoint, which compared the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by the mean change from baseline in A1C at 26 weeks. The trial also did not meet its secondary endpoint, which assessed the mean change from baseline in fasting plasma glucose at 26 weeks.
The New York-based pharma expects to discontinue its oral insulin clinical activities for type 2 diabetes.
The company's novel Protein Oral Delivery (POD) technology is designed to protect drug integrity and increase absorption — creating oral delivery solutions for drugs currently delivered via injection.
All is not entirely lost for ORMD-0801. The drug is still being studied in liver disease, currently in a phase 2 trial for patients with non-alcoholic steatohepatitis (NASH). There is currently no FDA approved treatment for NASH, which is expected to become an $84 billion market by 2029.
