ORMD 0901, a glucagon-like peptide-1 (GLP1) -analog could help in stimulating pancrease to release insulin according to the level of glucosse in the body, says Oramed.
Glucose dependent insulin releases means insulin will only be released if glucose levels are increased so that the risk of hypoglycemia due to excess insulin release is considerably reduced.
Oramed received approval from the Instututional Reveiw Board to commence human clinical trials of ORMD 0901, in September 2009, on the basis of successful preclinical results.
ORMD 0901 contains a glucagon-like peptide-1 (GLP-1) analogue as active ingredient.
Glucagon-like peptide-1 (GLP-1) analogue oris an incretin hormone – a type of gastrointestinal hormone that stimulates the secretion of insulin from the pancreas.
Glucagon is a hormone involved in regulation of glucose.
The a glucagon-like peptide-1 (GLP-1) analogue incretin concept was hypothesized when it was noted surprisingly that glucose ingested by mouth (oral) stimulated two to three times more insulin release than the same amount of glucose administered intravenously.
GLP-1 was found to stimulates insulin release, to suppress glucagon release from the pancreas, it slows gastric emptying to reduce the rate of absorption of nutrients into the blood stream, and it increases satiety.
GLP-1 also found increasing the number of beta cells (cells that manufacture and release insulin) in the pancreas and possibly to be hormone that protects the heart.
These attributes give GLP-1 an important edge among the available antidiabetic drugs.
While there are other drugs available which stimulate insulin release, none however enhances glucose dependent release.
GLP-1 also increases the satiety, which results in reduced food intake and consequent weight loss.
GLP-1 is only the second among the available antidiabetic drugs associated with weight loss, which is of utmost importance for people with diabetes.
GLP-1 is rapidly inactivated by an enzyme (dipeptidyl peptidase 4) as soon as it reaches the blood circulation.
Rapid inactivation has been an impediment to develop an exact copy of GLP-1 as a drug. GLP-1 will require administration by continuous infusion. Several long-lasting analogs with the same activity as GLP-1 have been developed. These analogues have either been approved for clinical use in the US or are in various stages of clinical studies.
Oramed Pharmaceuticals will present results of a ORMD 0901 GLP-1 analog oral administration study at the Diabetes Technology Society’s Ninth Annual Meeting in November at San Francisco, CA.
Oramed’s poster entitled “A novel GLP-1 analog delivered orally reduces postprandial glucose excursions in a porcine model,” the company announced.
Headquartered in Jerusalem, Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs and vaccines presently delivered via injection.
In August 2008, Oramed completed Phase 2A clinical trials of its oral insulin capsule ORMD 0801.
Oramed also conducted another Phase 2a study with Type 1 diabetic patients and positive results were reported in July of 2009. The oral insulin capsule ORMD 0801 was found safe, tolerable, and was not vulnerable to food effects.
Phase 1B trials were completed in March 2008 and were intended to find the optimal dosage of ORMD 0801.
ORMD 0801’s phase 2B clinical trials have commenced in the first quarter of 2009 in South Africa.