Medikox Exclusive Distributor Oral Insulin Also Effective for Non-Alcoholic Steatohepatitis... "Positive FDA Phase 2 Results"

[Asia Economy Reporter Jang Hyowon] MedicoX, a KOSDAQ-listed company, announced research results showing that ORMD-0801, an oral insulin therapy developed by Oramed Pharmaceuticals, a NASDAQ-listed U.S. company for which MedicoX holds exclusive domestic distribution rights, demonstrated efficacy in treating non-alcoholic steatohepatitis (NASH).

According to foreign media on the 13th (local time), Oramed's oral insulin therapy reportedly produced positive topline results in a Phase 2 U.S. Food and Drug Administration (FDA) trial for NASH.

This clinical trial was conducted on patients with type 2 diabetes (T2D) who have non-alcoholic steatohepatitis, aiming to reduce liver fat levels. It was a double-blind, randomized, placebo-controlled, multicenter clinical trial designed to evaluate the safety and efficacy of oral insulin.

When 32 patients were administered 8mg of oral insulin twice daily for 12 weeks, the results showed excellent safety and tolerability, with no difference in adverse reactions compared to the placebo group.

Furthermore, the liver fat reduction effect of oral insulin was evaluated using MRI-based MR PDFF (%), steatosis and fibrosis measured by Fibroscan, as well as lipid and glycated hemoglobin (HbA1c) levels, indicating clinically meaningful results.

Nadav Kidron, CEO of Oramed, stated, “These results are exciting as they suggest that oral insulin therapy can treat both diabetes and non-alcoholic steatohepatitis.” He added, “We are awaiting the topline data from the Phase 3 trial of oral insulin in type 2 diabetes patients expected in January 2023.”

Meanwhile, MedicoX has signed an exclusive domestic distribution and license agreement with Oramed for the oral insulin therapy. Under this contract, MedicoX is granted exclusive rights to the oral insulin therapy for 10 years from Oramed. It is currently reported that MedicoX is negotiating sales of the oral insulin through major domestic pharmaceutical companies.

The oral insulin therapy is currently undergoing FDA Phase 3 clinical trials across 96 clinical sites in the United States, involving 710 patients. The company expects it to be a game changer in the diabetes treatment market due to its superior efficacy compared to existing insulin injections.