JERUSALEM, Dec. 20, 2013 /PRNewswire/ — Oramed Pharmaceuticals Inc. (ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today successful results in a clinical trial testing the pharmacokinetic dose response of its oral insulin capsule (ORMD-0801) in type 1 diabetes patients.
Patients were treated with a different dose of oral insulin at each study visit; blood glucose and insulin levels were then monitored for the ensuing five hours. Patient responses positively correlated with administered doses, as did the duration of the effect.
“Based on these and the notable results from our previous oral insulin trials in type 1 diabetes, we continue to move forward with this indication in parallel to our advanced clinical studies in type 2 diabetes,” commented CEO Nadav Kidron.
Type 1 diabetes (T1DM) is an autoimmune disease wherein the body destroys its own insulin-producing cells, leaving patients completely dependent on external insulin sources. The disease, formerly known as juvenile diabetes, currently affects both young and adult populations. According to the International Diabetes Federation, T1DM is on the rise at a rate of 3% per year and currently affects approximately 36 million people worldwide – about 10% of the global diabetes population. The disease was formerly known as juvenile diabetes, and currently affects both young and adult populations.
About ORMD-0801 Oral Insulin and T1DM
T1DM is currently treated with two types of insulin replacement therapies: long-acting insulin (basal) to help maintain stable insulin levels during fasting periods, and pre-meal insulin (bolus) doses. Oramed proposes to introduce ORMD-0801 to replace the mealtime (bolus) insulin doses, which would significantly reduce the number of daily injections. Additionally, oral administration offers the benefit of reduced systemic exposure and may enable tighter regulation of blood sugar levels by directly affecting glucose control in the liver. For more information on ORMD-0801, the content of which is not part of this press release, please visit http://oramed.com/index.php?page=14
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs and vaccines currently delivered via injection. Established in 2006, Oramed’s Protein Oral Delivery (PODTM) technology is based on over 30 years of research by top research scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801) currently in Phase 2 clinical trials on patients with type 2 diabetes (T2DM) under an Investigational New Drug application with the U.S. Food and Drug Administration, and with its oral exenatide capsule (ORMD-0901; a GLP-1 analog), which has been assessed in healthy volunteers (Phase 1b) and is currently being tested in T2DM patients (Phase 2a). Oramed is also moving forward with clinical trials of ORMD-0801 for the treatment of type 1 diabetes. The company’s corporate and R&D headquarters are based in Jerusalem.
For more information, the content of which is not part of this press release, please visit www.oramed.com