Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, today reported additional data from the recently concluded Phase IIb trial of its oral insulin capsule ORMD-0801 in adults with type 2 diabetes. The data indicate a statistically significant lowering of glucose relative to placebo across several endpoints. Oramed had previously announced positive topline data showing the study successfully met its primary efficacy and safety endpoints. "ORMD-0801 was safe and efficacious in reducing blood glucose endpoints with a promising clinically meaningful reduction in the mean 24-hour blood glucose," said Dr. Roy Eldor, Oramed's Chief Medical Director, "We look forward to preparing the groundwork for a Phase III trial as we continue to bring this revolutionary product to market." The primary objective of the study was to evaluate the nighttime glucose lowering effect and safety of ORMD-0801 compared to a placebo. Excessive production of glucose at night is a significant challenge in diabetes management. Reducing nighttime blood glucose levels can significantly slow down the progression of diabetes and its life threatening comorbidities. In the study, the mean nighttime glucose showed a significant difference in mean change from run-in (13.70 mg/dL for placebo vs. 1.66 mg/dL for the pooled ORMD-0801 arms with a p= 0.0117). ORMD-0801 was safe and well tolerated, with no drug related serious or severe adverse events and no statistically significant differences in laboratory values or vital signs. Other secondary and exploratory objectives of the study included evaluating the effect of ORMD-0801 on mean 24-hour glucose, fasting glucose, and daytime glucose. The mean 24-hour glucose showed a highly significant difference in mean change from run-in (13.26 mg/dL for placebo vs. -0.32 mg/dL for ORMD-0801, p <0.0001). The mean fasting glucose showed a highly significant difference in mean change from run-in (15.95 mg/dL for placebo vs. -0.41 mg/dL for ORMD-0801, p <0.0001). The mean daytime CGM glucose showed a highly significant difference in mean change from run-in (11.88 for placebo vs. 0.88 for ORMD-0801, p= 0.0010). There was a statistically significant difference in change in HbA1c at Day 29 (0.20% for placebo vs.-0.01% for ORMD-0801, p= 0.0149). It is important to note that due to the kinetics of change of HbA1c, a four week study is insufficient to fully appreciate the potential positive impact of ORMD-0801 on HbA1c. ORMD-0801 did not show a significant difference in change in morning fasting serum insulin, C-Peptide, or triglycerides. A conference call on the results of the Phase IIb study will be held today, July 28, 2016, at 11:00 AM ET. Presentation slides to be used for the conference call are available at: http://www.oramed.com.
http://www.biospace.com/news_story.aspx?StoryID=427481&full=1
|
