Oramed Pharmaceuticals Reports Positive Top-Line Data from U.S. Phase IIa Trial with Oral Insulin in Type 1 Diabetes

//Oramed Pharmaceuticals Reports Positive Top-Line Data from U.S. Phase IIa Trial with Oral Insulin in Type 1 Diabetes

Oramed Pharmaceuticals Reports Positive Top-Line Data from U.S. Phase IIa Trial with Oral Insulin in Type 1 Diabetes

Demonstrates Proof-of-Concept for ORMD-0801 Oral Insulin to Reduce Exogenous Insulin Requirements

JERUSALEM, October 22, 2014 /PRNewswire/ —

Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (https://www.oramed.com ), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, today reported positive top-line clinical results from its Phase IIa clinical trial of ORMD-0801, the company’s proprietary oral insulin capsules, to treat type 1 diabetes. The trial was conducted in the United States under a U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) protocol.

The prospective, randomized, double-blind, placebo controlled study evaluated the safety and impact of ORMD-0801 given before meals on the exogenous insulin requirements in 25 established type 1 diabetic patients. The primary endpoint of the study was the change from baseline in exogenous insulin requirements (basal, bolus and total) in patients treated with ORMD-0801, compared to the change from baseline for patients treated with placebo. The secondary endpoint of the study was the change from baseline in mean nighttime, daytime and fasting glucose levels (by continuous glucose monitoring) in patients treated with ORMD-0801, compared to the change from baseline for patients treated with placebo.

The results showed that ORMD-0801 oral insulin given before meals appeared to be safe and well-tolerated for the dosing regimen in this study. Although the study was not powered to show statistical significance, there were internally consistent trends observed. Consistent with the timing of administration, the data showed a decrease in rapid acting insulin, a decrease in post-prandial glucose, a decrease in daytime glucose by continual glucose monitoring and an increase in post-prandial hypoglycemia in the active group.

“We are very pleased with the outcome of this study and look forward to sharing it with the scientific community,” commented Miriam Kidron, Ph.D., Chief Scientific Officer of Oramed. “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. 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.”

The company intends to hold a conference call on November 3rd, 2014 at 10:00 a.m. Eastern Time to present detailed data from the study. More details to follow.

About Type 1 Diabetes 

Type 1 diabetes is an autoimmune disease in which the pancreatic beta cells responsible for insulin secretion are attacked by the immune system. In the absence of self-produced insulin and the concomitant glycemic control, there is a need to supply extraneous insulin in order to regain glycemic control and prevent future disease complications that include heart disease, blood vessels disease, nerve and eye disease, infections, hypoglycemic events and many more ailments. According to the International Diabetes Federation, type 1 diabetes 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. The disease was formerly known as juvenile diabetes, and currently affects both pediatric and adult populations.

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 (POD™) technology is based on over 30 years of research by top 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). Having completed separate Phase IIa clinical trials in patients with both type 1 and type 2 diabetes, the company anticipates the initiation of separate Phase IIb clinical trials under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition, the company 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 https://www.oramed.com.

Forward-looking statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, we are using forward-looking statements when we discuss our clinical trials, including the expected timing thereof, and 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 Securities and Exchange Commission.

Company Contact Ariella Nachman Office: +972-2-566-0001 ext. 2
US: +1-718-831-2512 ext. 2
Email: ariella@oramed.com

SOURCE Oramed Pharmaceuticals Inc.

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