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Oramed Pharmaceuticals Advancing With an Oral Insulin

Oramed has screened the first patients in its global Phase 3 trials of its oral insulin capsule for the treatment of type 2 diabetes.



Israel’s Oramed Pharmaceuticals Inc. (Nasdaq/TASE: ORMP), is developing proprietary technology for the oral delivery of drugs presently administered by way of injection. It is moving forward with a new form of oral insulin for the treatment of diabetes.

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Oramed has screened the first patients in its global Phase 3 trials of its oral insulin capsule ORMD-0801 for the treatment of type 2 diabetes (T2D). The patients were screened at U.S. sites participating in Oramed’s ORA-D-013-1 trial, one of two Phase 3 trials being conducted in accordance with U.S. Food and Drug Administration approved protocols.

The Mayo Clinic explains that the underlying cause of diabetes varies by type. It causes a buildup of excess sugar in the blood. Too much sugar in your blood can lead to serious health problems.

Chronic diabetes conditions include type 1 diabetes and type 2 diabetes. Potentially reversible diabetes conditions include prediabetes and gestational diabetes. Prediabetes occurs when your blood sugar levels are higher than normal, but not high enough to be classified as diabetes.

Celebrities like Oscar winners Tom Hanks and Halle Berry are diabetics. So are Supreme Court Justice Sonia Sotomayor and former British Prime Minister Theresa May.

If you follow the news then you know that the rate of people who suffer from diabetes is growing. This is because of the prevalence of type 2 diabetes which is becoming an epidemic due to mass consumption of foods filled with added sugars and the wide increase in the levels of obesity in the west.

The World Health Organization sates that the number of people with diabetes rose from 108 million in 1980 to 422 million in 2014. The global prevalence of diabetes* among adults over 18 years of age rose from 4.7% in 1980 to 8.5% in 2014 and that between 2000 and 2016, there was a 5% increase in premature mortality from diabetes.

According to the American Diabetes Association, insulin was first isolated in the 1920s and fist mass produced for the treatment of diabetes in the 1930s. Insulin from animals such as pigs was first used, but this caused many complications. It was not until the 1980s that a synthesized form of human insulin was offered for the treatment of diabetics.

If you know a diabetic personally then you have probably seen them self-inject insulin from time to time. People generally fear needles and hate getting shots so you can imagine how awful it must be to need to self-inject all the time.

This is why the development of an oral insulin constitutes a remarkable breakthrough.

Through its patented flagship product, an orally ingestible insulin capsule currently in Phase 2 trials under the USFDA, the Company is seeking to revolutionize the treatment of diabetes.

“ORMD-0801 is the first oral insulin capsule to achieve the requisite efficacy and safety data enabling us to run the world’s first FDA Phase 3 oral insulin trial. Oramed is proud to lead the field in reaching this very significant diabetes treatment milestone,” stated Oramed CEO Nadav Kidron.



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