Oramed Reaches 50% Enrollment in its Second Phase 3 Oral Insulin Trial

Rhea-AI Summary

Oramed Pharmaceuticals announced that its Phase 3 trial, ORA-D-013-2, has reached over 50% enrollment of the targeted 450 patients for its oral insulin capsule, ORMD-0801, aimed at treating type 2 diabetes. This trial follows the completion of enrollment for the larger ORA-D-013-1 trial, which involved 710 patients. The trials mark the first Phase 3 oral insulin studies conducted under FDA oversight. The primary goal of ORA-D-013-2 is to assess the efficacy of ORMD-0801 compared to placebo in improving glycemic control over a 26-week period.

Positive

• Over 50% enrollment achieved in ORA-D-013-2 trial for ORMD-0801, significant progress towards completion.
• ORA-D-013-1 trial successfully completed enrollment with 710 patients, indicating robust interest and participation.
• Potential to introduce the first commercial oral insulin capsule if successful in ongoing trials.

Negative

• None.

-  ORA-D-013-2 is the second of two Phase 3 trials under FDA protocol

-  ORA-D-013-1, the larger of the two trials, completed enrollment with top line data expected January 2023

NEW YORK, July 26, 2022 /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 50% of the planned 450 patients for its international multicenter 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) Investigational New Drug Application (IND) to treat T2D patients who have inadequate glycemic control over a period of 6 to 12 months.

"We are very pleased as we head into the latter half of enrollment for our ORA-D-013-2 trial, especially after having just completed 100% enrollment in our larger ORA-013-1 trial which randomized a total of 710 patients. Together, these trials are the world's first Phase 3 oral insulin trials conducted under a U.S. FDA IND," said Oramed's Chief Executive Officer, Nadav Kidron.

About the Trial
The ORA-D-013-2 trial is recruiting 450 T2D patients with inadequate glycemic control who are managing their condition with either diet alone or with diet and metformin monotherapy. The double-blind trial will randomize patients 1:1 into two cohorts dosed with 8 mg of ORMD-0801 at night or placebo at night. The primary endpoint of the trial 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 is being evaluated in two pivotal Phase 3 studies and has the potential to be the first commercial oral insulin capsule for the treatment of diabetes. 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 expected release of top-line data for ORA-D-013-1, as well as 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.

Company Contact:
Zach Herschfus
+1-844-9-ORAMED
zach@oramed.com

Logo: https://mma.prnewswire.com/media/1724339/Oramed_Logo.jpg

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SOURCE Oramed Pharmaceuticals Inc.

FAQ

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

The ORA-D-013-2 trial is designed to evaluate the efficacy of ORMD-0801, an oral insulin capsule, for treating type 2 diabetes in patients with inadequate glycemic control.

When is the expected data release for ORA-D-013-1 trial?

Top-line data for the ORA-D-013-1 trial is expected in January 2023.

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 a 26-week treatment period, while a secondary endpoint evaluates maintenance of glycemic control over 52 weeks.

What are the implications if ORMD-0801 is successful?

If successful, ORMD-0801 could become the first commercial oral insulin capsule for diabetes management, potentially transforming treatment options.

How many patients are being recruited for the ORA-D-013-2 trial?

The ORA-D-013-2 trial is recruiting a total of 450 patients.