November 10, 2020

Impact: Moderate

Oramed is planning two new phase 2 studies to evaluate the efficacy and safety of its oral insulin candidate, ORMD-0801 in T2DM patients with NASH. The studies are due to start in November 2020.

  • The first study is a double-blind study that will randomize 36 subjects in a 2:1 ratio to receive either 8 mg ORMD-0801 or placebo.
    • Patients will receive one capsule twice a day (once in the morning approximately 30 to 45 minutes prior to breakfast and no later than 10 AM, and once at night between 8 PM to Midnight and no sooner than 1 hour after dinner).
  • The second study is an open-label study to evaluate once-daily and twice daily regimens of ORMD-0801. Patients will receive either 8 mg QD or 8 mg BID.
  • Both studies are primarily safety studies that will evaluate preliminary efficacy as secondary outcome measures.
  • The studies are due to readout at the end of 2021.

inThought Analysis

Preliminary observations in a very small number of T2DM patients with NASH in a T2D study were presented at the American Diabetes Association (ADA) meeting earlier this year, and supported the further development of ORMD-0801 as a potential treatment for NASH.

Source: (NCT04618744), (NCT04616014)