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Oral insulin phase 2 study results expected by year end

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Oramed Pharmaceuticals recently completed recruitment and randomization for a phase 2b study assessing the safety and efficacy of an oral formulation of human insulin, according to a company press release.

The company’s lead oral insulin candidate, ORMD-0801, is currently being evaluated in an ongoing phase 2b, double-blind, randomized clinical trial with nearly 300 patients with type 2 diabetes, according to the company. The study will assess the primary efficacy endpoint of reduction in HbA1c, as well as safety endpoints. More than 80% of patients (n = 287) completed treatment, and results are expected in the fourth quarter of 2019. Findings from a secondary cohort of patients within the study assigned to lower doses of ORMD-0801 are expected in the first quarter of 2020.

“Oramed has the potential to succeed in areas where other companies developing an oral insulin have failed,” Miriam Kidron, PhD, chief scientific officer of Oramed, told Endocrine Today. “Oramed will have the results of our pivotal phase 2 study in oral insulin before the end of the year. With this, Oramed anticipates proceeding to a phase 3 trial.”

The company’s proprietary technology is unique, Kidron said, because it protects drug integrity in the stomach and increases absorption.

 

Oramed Pharmaceuticals recently completed recruitment and randomization for a phase 2b study assessing the safety and efficacy of an oral formulation of human insulin.

Source: Adobe Stock

“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,” Kidron said. “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.”

In addition to oral insulin, the company recently completed a small phase 1k 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. 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.

“Oramed’s proof-of-concept, single-dose study examining glucagon reduction, the first in humans, is planned to begin in the third quarter of 2019,” Kidron said. – by Regina Schaffer

Disclosure: Kidron is chief scientific officer at Oramed.