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news.Oramed Pharmaceuticals has reported positive top-line clinical results from a Phase IIa clinical trial of its proprietary oral insulin capsules ORMD-0801, to treat type 1 diabetes.
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The prospective, randomized, double-blind, placebo controlled trial was carried out in the US under a US Food and Drug Administration (FDA) Investigational New Drug (IND) protocol.
The trial assessed the safety and impact of ORMD-0801 given before meals on the exogenous insulin requirements in 25 established type 1 diabetic patients.
Its primary endpoint was the change from baseline in exogenous insulin requirements in patients treated with ORMD-0801, compared to the change from baseline for patients treated with placebo.
The trial’s secondary endpoint was the change from baseline in mean nighttime, daytime and fasting glucose levels in patients treated with ORMD-0801, compared to the change from baseline for patients treated with placebo.
Oramed chief scientific officer Miriam Kidron said the company is happy with the outcome of this study and look forward to sharing it with the scientific community.
"We continue to build our body of human clinical data in support of the use of ORMD-0801 to treat both type 1 and type 2 diabetes," Kidron said.
"With the data gathered so far, we look forward to initiating our Phase IIb study of ORMD-0801 in type 2 diabetes patients later this year."