JERUSALEM, July 28, 2016 /PRNewswire/ --
Statistically Significant Results Across Key Glycemic Endpoints
Conference Call Today at 11:00 AM ET
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.
To participate, please call: UK/International dial in number: +44-145-255-5566, US Toll free dial in number: 1-866-966-9439; Conference code: 53919552
About the Study [ORA-D-007]
The randomized, double-blind Phase IIb study was conducted in 33 sites across the United States, and included 180 adults with type 2 diabetes, whose diabetes was not adequately managed through proper diet and medication (Metformin) alone. Due to technical inaccuracies that can occur in any diabetes study, measuring glucose changes with continuous glucose monitors (CGM), data can include extreme outliers. To reduce variability, trimming of unlocked, fully blinded information was conducted. In the current summary, the 80% trimmed data (data excluding the 10% highest and lowest values) is presented.
For more information on the study, which does not form a part of this press release, see: https://clinicaltrials.gov/ct2/show/NCT02496000?term=oramed&rank=5
About ORMD-0801 Capsule for Type 2 Diabetes
Intestinally-absorbed oral insulin mimics insulin's natural location and gradients in the body by first passing through the liver before entering the bloodstream. ORMD-0801 has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment, potentially slowing disease progression and delaying or eliminating late-stage complications. Orally administered insulin is also expected to enhance patient compliance.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, Oramed's Protein Oral Delivery (PODTM) technology is based on over 30 years of research by 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). The Company completed multiple Phase II clinical trials under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition, Oramed is developing an oral GLP-1 analog capsule (ORMD-0901).
For more information, the content of which is not part of this press release, please visit http://www.oramed.com
Forward-looking statements: This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss that our China patent is an important milestone which paves our entrance into the US diabetes market, that ORMD-0801 has the potential to create a new paradigm in the treatment of diabetes, potentially slowing disease progression and delaying or even eliminating late-stage complications, that orally administered insulin should bring with it enhanced patient compliance or revolutionizing the treatment of diabetes with our products. These forward-looking statements are based on the current expectations of the management of Oramed only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; laboratory results that do not translate to equally good results in real settings; our patents may not be sufficient; and final that products may harm recipients, all of which could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Oramed undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Oramed, reference is made to Oramed's reports filed from time to time with the SEC.
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SOURCE Oramed Pharmaceuticals Inc.