Oramed Initiates Its 90-Day Pivotal Dose-Ranging Clinical Study for Oral Insulin

90-day dosing study is a prerequisite to Phase 3 confirmatory studies under FDA’s BLA

NEW YORK, April 23, 2018 /PRNewswire/ —  Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today it has begun screening patients in its 90-day dose-ranging Pivotal Phase 2b HbA1c clinical study of its oral insulin capsule, ORMD-0801.

Oramed Pharmaceuticals logo

A statistically significant improvement in HbA1c (glycated hemoglobin), a long-term gauge of blood glucose control, was observed in just 28 days of treatment with ORMD-0801 in Oramed’s prior Phase 2 study. The purpose of this study is to measure this effect over 90 days of treatment at different doses.

The study will enroll approximately 240 patients with type 2 diabetes in multiple centers throughout the U.S. The primary end points are safety evaluating adverse and hypoglycemic events, and efficacy specific to HbA1c levels over 90 days of treatment. Secondary end points include measures of fasting plasma glucose (FPG), post-prandial glucose (PPG levels) during a mixed-meal tolerance test (MMTT) and weight.

“We are very pleased to move forward with this important 90-day treatment study to measure the potential longer-term benefits of our oral insulin capsule on HbA1c in type 2 diabetics,” stated Oramed CEO, Nadav Kidron.

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 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). 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 www.oramed.com.

Forward-looking statements: This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss the potential long term benefits of Oramed’s oral insulin capsule, the timing of expected clinical development programs and clinical trials and FDA submissions 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 U.S. Securities and Exchange Commission.

Company Contact
Oramed PharmaceuticalsJosh Hexter1 844 9 ORAMED ext. 2
Email:  josh@oramed.com


Cision View original content:http://www.prnewswire.com/news-releases/oramed-initiates-its-90-day-pivotal-dose-ranging-clinical-study-for-oral-insulin-300634278.html

SOURCE Oramed Pharmaceuticals Inc.

You may also be interested

Join our mailing list

Skip to content