Oramed Reaches 25% Enrollment in Its Second of Two Concurrent Phase 3 Oral Insulin Trials

Rhea-AI Summary

Oramed Pharmaceuticals has announced the enrollment of over 25% of its target of 450 patients in the Phase 3 ORA-D-013-2 trial for its oral insulin capsule, ORMD-0801, aimed at treating type 2 diabetes. This trial is one of two ongoing Phase 3 trials approved by the FDA. The study will assess the efficacy of ORMD-0801 in improving glycemic control compared to placebo over 26 weeks, with a secondary aim to maintain control over 52 weeks. Results from the concurrent ORA-D-013-1 trial, which enrolled nearly 65% of its 675 patients, are expected in 2022.

Positive

• Over 25% of patients enrolled in Phase 3 ORA-D-013-2 trial for ORMD-0801.
• Trial is one of the first Phase 3 oral insulin studies under FDA protocols.
• Concurrent ORA-D-013-1 trial is nearing completion with results expected in 2022.

Negative

• None.

NEW YORK, Aug. 24, 2021 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, announced today that it has enrolled and randomized over 25% of the planned 450 patients for its Phase 3 ORA-D-013-2 trial of its oral insulin capsule ORMD-0801 for the treatment of type 2 diabetes (T2D).

ORA-D-013-2 is the second of Oramed's two Phase 3 trials being conducted under U.S. Food and Drug Administration (FDA) approved protocols to treat T2D patients who have inadequate glycemic control over a period of 6 to 12 months. The concurrent trial, ORA-D-013-1, completed enrollment and randomization of nearly 65% of its 675 planned patients and is on track to complete randomization with topline results expected in 2022.

"We are pleased with the pace of patient enrollment in the world's first Phase 3 oral insulin trials conducted under a U.S. FDA protocol, and look forward to providing further updates," said Oramed Chief Executive Officer, Nadav Kidron.

About the Study

The ORA-D-013-2 study is recruiting 450 T2D patients with inadequate glycemic control who are managing their condition with either diet alone or with diet and metformin monotherapy. Patients are being recruited through 28 sites in the U.S. and 25 sites in Western Europe and Israel. The double-blind study will randomize patients 1:1 into two cohorts dosed with 8 mg of ORMD-0801 at night and placebo at night. The primary endpoint of the study is to compare the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by A1c over a 26-week treatment period, with a secondary endpoint of comparing ORMD-0801 to placebo in maintaining glycemic control over a 52-week treatment period.

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. Established in 2006, with offices in the United States and Israel, Oramed has developed a novel Protein Oral Delivery (POD™) technology. Oramed is seeking to transform the treatment of diabetes through its proprietary lead candidate, ORMD-0801, which has the potential to be the first commercial oral insulin capsule for the treatment of diabetes. The Company has 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 (Glucagon-like peptide-1) analog capsule, ORMD-0901.

For more information, 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 pace of enrollment and randomization and expected timing of topline results of our Phase 3 studies or the potential of ORMD-0801 to be the first commercial oral insulin capsule for the treatment of diabetes. 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 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 finally 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.

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Company Contact:
Josh Hexter
+1-844-9-ORAMED
josh@oramed.com

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SOURCE Oramed Pharmaceuticals Inc.

FAQ

What is the purpose of the ORA-D-013-2 trial for ORMD-0801?

The ORA-D-013-2 trial aims to evaluate the efficacy of the oral insulin capsule ORMD-0801 in improving glycemic control in type 2 diabetes patients.

How many patients does Oramed Pharmaceuticals plan to enroll in the ORA-D-013-2 trial?

Oramed plans to enroll a total of 450 patients in the ORA-D-013-2 trial.

What are the primary and secondary endpoints of the ORA-D-013-2 trial?

The primary endpoint is to compare the efficacy of ORMD-0801 to placebo in improving glycemic control over 26 weeks, while the secondary endpoint assesses maintenance of glycemic control over 52 weeks.

When are the topline results of the ORA-D-013-1 trial expected?

Topline results from the ORA-D-013-1 trial are expected to be reported in 2022.

What type of patients are being recruited for the ORA-D-013-2 trial?

The trial is recruiting type 2 diabetes patients with inadequate glycemic control who are managing their condition through diet alone or with metformin.