ORMD-0901 - Oral Exenatide Capsule
ORMD-0901 - Oral Exenatide Capsule

GLP-1

Glucagon-like peptide-1 (GLP-1) is an incretin hormone - a gastrointestinal hormone that stimulates the secretion of insulin from the pancreas. The incretin effect, in which gut-derived factors enhance insulin secretion from the pancreas, was first hypothesized when it was noted that two to three times more insulin was released after ingestion of glucose by mouth (oral) than after intravenously delivered glucose.
In addition to stimulating insulin release, GLP-1 was found to:

  • suppress glucagon release (hormone involved in regulation of glucose) from the pancreas
  • slow gastric emptying to reduce the rate of absorption of nutrients into the bloodstream
  • increase satiety
  • increase the number of beta cells - pancreatic cells that manufacture and release insulin
  • possibly feature cardioprotective (heart-protecting) qualities

Exenatide: A GLP-1 analog

GLP-1 is rapidly inactivated in the blood by an enzyme (dipeptidyl peptidase-4), a phenomenon which has triggered development of several long-lasting analogs with the same activity as GLP-1. Exenatide, a GLP-1 analog, is currently marketed in injectable forms only, and is indicated for treatment of T2DM. While there are other drugs available which stimulate insulin release, none enhance glucose-dependent insulin release. In contrast, exenatide only induces insulin release when glucose levels are increased; the risk of hypoglycemia due to excess insulin release is considerably reduced [1].
One other distinguishing attribute of exenatide is the increase in satiety it induces, which results in reduced food intake and consequently to weight loss. Exenatide is one of the two available antidiabetic drugs associated with weight loss, which is of utmost importance for people with diabetes.
Some of exenatide's benefits include:

  • mimics naturally produced GLP-1
  • aids in the balance of blood sugar levels by decreasing glucose levels, particularly after a meal
  • effectively reduces HbA1c
  • preserves beta cell function
  • promotes weight loss
  • does not cause hypoglycemia

Exenatide has an excellent safety profile and a plethora of positive medicinal effects. In its current injectable form, however, it induces severe nausea in a large percentage of treated patients, leading patients to decline this treatment option or to terminate treatment after a short time - despite its benefits.

Oramed's Oral Exenatide Solution

In September 2009, Oramed commenced human clinical trials of ORMD-0901, an oral exenatide capsule. In addition to offering the clinical benefits of the intravenously administered exenatide, Oramed's oral exenatide analog proved safe and tolerable and did not induce nausea in the monitored patients.

An oral dosing of exenatide could greatly increase patient compliance and promises to become a valuable tool in the treatment of T2DM.

ORMD-0901: Current Status

  • Pre-IND (Investigational New Drug) package submitted to FDA Sept 2013 - press release

  • Phase Ib/IIa trials initiated January 2013

Clinical Trial History  

View Chart


[1] Hypoglycemia is when blood sugar levels drop abnormally low and is most commonly caused by excess circulating insulin.

 

Scientific Abstract

A Single-Blind Two-Period Study to Assess the Safety and Pharacodynamics of an Orally Delivered GLP-1 Analog (Exenatide) in Healthy Subjects

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Scientific Abstract

A novel GLP-1 analog delivered orally reduces postprandial glucose excursions in a porcine model

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