By Gabrielle Masson Sep 13, 2022 11:20am
Oramed Pharmaceuticals has posted encouraging phase 2 results for its oral insulin candidate designed to treat diabetes and non-alcoholic steatohepatitis (NASH). The company now awaits phase 3 readouts for the candidate that holds potential to become the first commercial oral insulin capsule for treating diabetes.
The double-blind, placebo-controlled trial assessed the safety and efficacy of Oramed’s candidate—dubbed ORMD-0801—among 30 patients with type 2 diabetes and NASH, according to a Sept. 13 release. The 12-week trial results found ORMD-0801 to be safe and well tolerated at an 8 mg twice daily dosing, achieving the trial’s main target with no difference in adverse events for ORMD-0801 compared to placebo.
The trial also found several independent measures demonstrated a “consistent clinically meaningful trend” that favored ORMD-0801 for reducing liver fat content.
“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 CEO Nadav Kidron.
The New York-based 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.
In August, Novo Nordisk CEO Lars Fruergaard Jørgensen told Fierce Pharma that while the ambitions are among Novo’s “most risky” R&D endeavors, the payoff for patients could be “tremendous.”
“NASH is not an easy place to go,” Jørgensen acknowledged. “Honestly, not a lot of it has come out positive,” the CEO said of other industry efforts.