Oramed Pharmaceuticals has released results of a Phase IIa clinical trial of its ORMD-0801, an oral insulin capsule for the treatment of type 2 diabetes.
The trial was carried out under a US Food and Drug Administration (FDA) IND (Investigational New Drug) protocol, and it met all primary and secondary endpoints.
A total of 30 patients with type 2 diabetes participated in the trial in an in-patient setting for one week.
In the trial, endpoints of safety as well as pharmacodynamic and pharmacokinetic effects were evaluated against a placebo control.
Oramed CEO Nadav Kidron said the company is happy with the results which give a solid validation for its platform technology in general and its oral insulin program in particular.
“Following on the results from this type 2 diabetes study we are gearing up to start a multi-center Phase 2b study later this year,” Kidron said.
“We are also excited about the potential of this drug for type 1 diabetes and plan to initiate a Phase 2a FDA study for this indication in the near term.”
ORMD-0801 is an orally ingestible insulin capsule for the early stages of type 2 diabetes, when it can still slow the rate of degeneration of the disease by providing additional insulin to the body and allowing pancreatic respite.