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Oral insulin demonstrates safety, efficacy in phase 2b trial
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Adults with type 2 diabetes assigned an oral formulation of human insulin achieved a clinically meaningful reduction in HbA1c compared with those assigned placebo, according to a press release from Oramed Pharmaceuticals.
The positive top-line results from the phase 2b trial, which enrolled 269 adults with type 2 diabetes, demonstrated safety and efficacy for ORMD-0801, the company’s lead oral insulin candidate, according to the release. The drug has the potential to be the first commercial oral insulin capsule for the treatment of diabetes.
“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,” Nadav Kidron, CEO of Oramed, said in the release. “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 FDA about phase 3 trials. We are enthusiastic about ORMD-0801’s potential as we transition into the final stages of development.”
As Endocrine Today previously reported, the placebo-controlled, double-blind, randomized controlled trial enrolled adults with type 2 diabetes inadequately controlled with oral diabetes agents. Researchers assessed change in HbA1c from baseline to week 12, as well as safety endpoints, when oral insulin was given in different regimens across a dose range.
Adults assigned once-daily ORMD-0801 achieved a reduction in mean HbA1c of 0.6% from baseline, according to the release, or a mean reduction of 0.54% adjusted for placebo (P = .036).
“This 0.54% reduction in HbA1c is considered clinically meaningful, reflecting an improved glucose control that would result in reduced risk of developing diabetes-related complications,” the company stated in the release.
There were no serious drug-related adverse events and no increased frequency of hypoglycemic episodes, according to the company. There was no weight gain observed among participants during the 90-day trial.
“This phase 2b study provides statistically significant efficacy data, which, coupled with no reported hypoglycemia, support a unique mechanism of action of Oramed’s oral insulin,” Joel M. Neutel, MD, director of research at the Orange County Research Center in Tustin, California, and a principal investigator in the phase 2b trial, said in the release. “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 hypoglycemia and weight gain.”
In addition to oral insulin, the company recently completed a small phase 1 pharmacokinetic trial of an oral GLP-1 analogue of exenatide (Byetta, AstraZeneca) for type 2 diabetes, ORMD-901, under the company’s existing FDA investigational new drug application, and is conducting a 3-month exploratory clinical trial with ORMD-0801 for the treatment of nonalcoholic steatohepatitis, Kidron said in a separate company press release. Oramed is also conducting an exploratory trial with an oral leptin capsule to evaluate glucagon reduction in type 1 diabetes, with a long-term goal of addressing weight loss. – by Regina Schaffer
Disclosures: Kidron is CEO of Oramed. Endocrine Today could not confirm relevant financial disclosures of Neutel at the time of publication.