Oramed Pharmaceuticals announced positive results from the initial cohort of the Phase IIb trial evaluating the efficacy and safety of its lead oral insulin candidate, ORMD-0801, which has the potential to be the first commercial oral insulin capsule for the treatment of diabetes.
The placebo-controlled, double-blinded, randomized, 90-day dose-ranging phase IIb trial in type 2 diabetes (T2D) patients with inadequate glycemic control on oral antihyperglycemic agents, assessed the change in A1C, the primary efficacy endpoint, from baseline to week 12, as well as safety endpoints, when ORMD-0801 was given in different regimens across a dose range.
Patients randomized in the trial to once-daily ORMD-0801 achieved a reduction in mean A1C of 0.60% from baseline, or a reduction of 0.54% adjusted for placebo (p value = 0.036). This 0.54% reduction in A1C is considered clinically meaningful, reflecting an improved glucose control that would result in reduced risk of developing diabetes-related complications.
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Treatment with ORMD-0801 demonstrated an excellent safety profile, with no serious drug-related adverse events and with no increased frequency of hypoglycemic episodes. In addition, during this 90-day trial, no weight gain was observed.
"These results further demonstrate that ORMD-0801 is a safe and efficacious insulin treatment for improving disease management for the millions of people living with diabetes,” Oramed's Chief Executive Officer, Nadav Kidron, said. “As a next step, we look forward to the read-out of data from a second cohort of the trial in the first quarter of 2020 and further discussions with the U.S. FDA about Phase III trials. We are enthusiastic about ORMD-0801's potential as we transition into the final stages of development."
"This Phase IIb study provides statistically significant efficacy data which, coupled with no reported hypoglycaemia, support a unique mechanism of action of Oramed's oral insulin,” Joel M. Neutel, MD, the Principal Investigator of the Phase IIb trial of ORMD-0801, said. “The intestinal absorption of insulin enables direct delivery of insulin to the liver mimicking the natural transport of insulin in the body. The result is a more physiologic replacement of insulin, leading to an effective treatment with less risk of hypoglycaemia and weight gain. Based on these positive results and the demonstrated meaningful reduction in A1C in T2D patients, with inadequate blood glucose control, many of whom were on multiple diabetes medications, I believe the use of ORMD-0801 could be clinically beneficial to patients."
Dr. Neutel is the Director of Research at Orange County Research Center in Tustin, California.