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Phase 3 on the horizon
January 2020
by Kelsey Kaustinen  |  Email the author
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NEW YORK—An estimated 30 million people in the United States currently have diabetes, nearly 10 percent of the country's total population. Worldwide, the total number was 422 million in 2014, according to the World Health Organization, with an estimated 1.6 million deaths attributed to diabetes in 2016. As Western diets and lifestyle impacts lead to rising incidence, and as injectable insulin costs continue to skyrocket, an oral insulin option has become a common goal to make disease management easier for diabetic patients.
 
One of the frontrunners in the race for the first oral insulin drug is Oramed Pharmaceuticals Inc., which announced in Q4 2019 that it had positive data from the first cohort of its Phase 2b trial of ORMD-0801. The placebo-controlled, double-blinded, randomized trial is assessing the safety and efficacy of the oral insulin candidate in individuals with type 2 diabetes and inadequate glycemic control on oral antihyperglycemic agents. A reduction in A1C at week 12 was the primary efficacy endpoint, with various safety endpoints also being evaluated. Should ORMD-0801 continue to be successful in the clinic, it could be the first commercialized oral insulin capsule treatment for diabetes.
 
“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. 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. 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,” commented Dr. Joel M. Neutel, principal investigator and director of research at Orange County Research Center in Tustin, Calif.
 
Patients who received once-daily ORMD-0801 saw a reduction in their mean A1C of 0.60 percent from baseline, or a reduction of 0.54 percent when adjusted for placebo—a clinically meaningful improvement in glucose control. No serious drug-related adverse events were reported, and there was no noted weight gain or increase in the frequency of hypoglycemic episodes.
 
During an investor event to discuss the Phase 2b results, Dr. Ramachandra Naik, Professor of Medicine/Endocrinology at SUNY Upstate Medical University, noted that the results show ORMD-0801 could serve as a second-, third- or fourth-line oral agent for individuals with diabetes, with Dr. Joel Neutel, principal investigator of the study and director of Research at Orange County Research Center, adding that the compound is also capable of being administered alongside other glucose-lowering agents. According to Naik, patients taking more than one antihyperglycemic agent points to a more advanced stage of disease, and ORMD-0801's benefit in such patients in this study was “clinically really very significant.”
 
“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,” said Oramed’s CEO, Nadav Kidron. “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 3 trials. We are enthusiastic about ORMD-0801’s potential as we transition into the final stages of development.”
 
A second cohort is ongoing to determine the optimal dose of ORMD-0801 for the pending Phase 3 trial, with 75 patients having been randomized into five groups: 8 mg dosed once-daily; 8 mg dosed twice-daily; 16 mg dosed once-daily; 16 mg dosed twice-daily; and placebo dosed twice-daily. Results from this cohort are expected in the first quarter of the year.
 
Novo Nordisk was pursuing its own oral basal insulin, I338, and published results in Lancet Diabetes & Endocrinology in Q1 2019 showing feasibility. However, the company discontinued the program due to issues of commercial viability regarding effective dose levels and quantities.
 
Code: E012002

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