Low-dose oral insulin safe, effective in phase 2b trial
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Oramed Pharmaceuticals this week announced positive top-line data from the second and final cohort of its phase 2b trial evaluating the efficacy and safety of oral insulin, which demonstrated that a once daily low dose was associated with a reduction in HbA1c with no increase in hypoglycemia or weight gain during 12 weeks, according to an industry press release.
The company’s lead oral insulin candidate, ORMD-0801, has the potential to be the first commercially available oral insulin capsule for the treatment of diabetes.
“We believe the strong efficacy shown while treating patients at a lower dose further demonstrates ORMD-0801’s potential as a safe, noninvasive and effective oral insulin solution for the millions of people suffering from diabetes worldwide,” Nadav Kidron, CEO of Oramed, said in the release. “Following this conclusion of our phase 2b trial, we are excited to further discuss with the FDA our planned phase 3 trial.”
In a randomized, double-blind, placebo-controlled trial, researchers analyzed data from 78 adults with type 2 diabetes inadequately controlled with oral diabetes agents. Researchers randomly assigned participants to one of five groups: 8 mg oral insulin dosed once daily, 8 mg dosed twice daily, 16 mg dosed once daily, 16 mg dosed twice daily, and placebo dosed once daily for 12 weeks. Two sites were excluded from the statistical analysis in the primary cohort due to evidence of treatmentbycenter interaction and a statistically significant placebo effect (n = 13). Primary efficacy endpoint was a reduction in HbA1c at week 12. Of the 65 patients included in the analysis, 57 completed the study.
The once-daily and twice-daily arms assigned the 8-mg dose achieved HbA1c reductions from baseline 0.95% (0.81% with placebo adjustment; P = .028) and 0.95% (0.82% with placebo adjustment; P = .029), respectively. Researchers did not observe a reduction in HbA1c for participants in the 16 mg once-daily and twice-daily dosing arms, according to the release.
Additionally, participants with an HbA1c of at least 9% at baseline assigned 8 mg oral insulin once daily experienced a 1.26% reduction in HbA1c by week 12. There were no serious drug-related adverse events, hypoglycemia or weight gain.
In an interview with Healio shortly after Oramed completed recruitment and randomization for the study, Miriam Kidron, PhD, chief scientific officer of Oramed, said the company’s proprietary technology is unique because it protects drug integrity in the stomach and increases absorption.
“By mimicking the natural biological process of how insulin affects the liver, Oramed is able to generate superior insulin levels without the adverse side effects of other injectable treatments,” Miriam Kidron told Healio in July. “If we start with oral insulin earlier in the treatment paradigm, then physicians are able to better control their patients’ diabetes and, hopefully, postpone or delay insulin injections.”
As Healio previously reported, 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.
The company said it plans to move forward with a phase 3 trial of the drug. – by Regina Schaffer
Disclosures: Nadav Kidron is CEO of Oramed. Miriam Kidron is chief scientific officer of Oramed.