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Oral Insulin Capsule
In May 2010, the Company reported results for the recently completed Phase 2b non-FDA clinical trial of its flagship oral insulin capsule, ORMD-0801.
The randomized, double-blind, placebo-controlled, multi-centered study in South Africa evaluated responses of Type 2 diabetes patients to ORMD-0801. Insulin-loaded or placebo capsules were administered to patients, who were closely monitored throughout the 6-week study period. Safety, tolerability and efficacy parameters of Oramed’s oral insulin were assessed. The reported results substantiate the safety and tolerability of ORMD-0801 and demonstrate that oral insulin has a relevant clinical impact at the tested dose.
In August 2008, Oramed successfully completed Phase 2A clinical trials of its oral insulin capsule. This trial was the first to expose patients with type 2 diabetes to ORMD 0801 and its primary goals were to assess the safety, tolerability and pharmcodynamic effects in these patients. ORMD 0801 was well tolerated by all patients and had a good safety profile; no serious adverse events were encountered throughout the study. In two thirds of the subjects analyzed, statistically significant reductions in glucose as well as C-peptide were observed.
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 was 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. These trials were conducted with healthy volunteers.
In August 2007, Phase 1A clinical trials were completed, the goal of which was to assess both the safety/tolerability and absorption properties of Oramed's proprietary delivery technology. The trials examined changes in insulin, glucose and C-peptide plasma concentrations over time in healthy volunteers under several differing oral dosing scenarios. |
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