Oramed Announces Top-line Results from Phase 3 Trial of ORMD-0801 for the Treatment of Type 2 Diabetes
NEW YORK, Jan. 11, 2023 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq/TASE: ORMP), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, announced today top-line results from its Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical trial (ORA-D-013-1) comparing the efficacy of ORMD-0801 to placebo in patients with Type 2 Diabetes (T2D) at 26 weeks. ORA-D-013-1 enrolled 710 patients with T2D and inadequate glycemic control on two or three oral glucose-lowering agents.
The ORA-D-013-1 trial did not meet its primary endpoint, which compared the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by the mean change from baseline in A1C at 26 weeks. The trial also did not meet its secondary endpoint, which assessed the mean change from baseline in fasting plasma glucose at 26 weeks. There were no serious drug-related adverse events. Therefore, Oramed expects to discontinue its oral insulin clinical activities for T2D.
Nadav Kidron, Oramed's Chief Executive Officer, commented, "Today's outcome is very disappointing, given the positive results from prior trials. Once full data from the studies are available, we expect to share relevant learnings and future plans. We thank all the patients, families and healthcare professionals who participated in the trial."
Additional Information About the ORA-D-013-1 Phase 3 Clinical Trial
In the ORA-D-013-1 trial, patients were randomized 2:2:1:1 into four groups: 8 mg dosed once-daily; 8 mg dosed twice-daily; placebo dosed once-daily; and placebo dosed twice-daily. Patients completed an initial 21-day Screening Period, followed by a 26-week Double-Blind Treatment Period. More information on the trial can be found here: ORA-D-013-1.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals (Nasdaq/TASE: ORMP) is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. The Company's novel Protein Oral Delivery (POD™) technology is designed to protect drug integrity and increase absorption. Oramed has offices in the United States and Israel. For more information, please visit www.oramed.com.
This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss our future strategy, plans and prospects, providing further clinical and business updates based on additional analyses, and our discontinuation of clinical trial activities for ORMD-0801. In addition, historic results of scientific research and clinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. 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 risk that the Company may not be able to successfully implement its strategic plans; the risks and uncertainties related to the progress, timing, cost, and results of current and future 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; that products may harm recipients; and other factors discussed in the "Risk Factors" section of the Company's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, each of which is on file with the Securities and Exchange Commission and in other filings that the Company makes with the Securities and Exchange Commission in the future. All of these factors and uncertainties 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.
SOURCE Oramed Pharmaceuticals Inc.
Company Codes: NASDAQ-SMALL:ORMP, TelAviv:ORMP