Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, has announced 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.
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. Further information on ORMD-0801 can be found here.