- Topline Pivotal Phase 3 Oral Insulin Data Expected Mid-January 2023
- Phase 2 NASH Trial Achieved Primary and Secondary Endpoints
- Definitive Deal Signed to Commercialize Oral Insulin in South Korea
- $160 Million in Cash and Investments (as of September 30, 2022)
NEW YORK, Dec. 21, 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, today issued a Letter to Shareholders from its Chief Executive Officer, Nadav Kidron.
Dear Shareholders and wider investor community,
The year 2022 was a very strong year for Oramed. The first of our two Phase 3 oral insulin trials, ORA-D-013-1, completed enrollment with a wider scope of patients than originally planned, and we expect to announce topline results in mid-January 2023. Concurrently, our Phase 2 NASH trial delivered positive efficacy and safety data. We finished out the third quarter with $160 million in cash and investments with no debt, giving us a long runway through topline results for both of our Phase 3 oral insulin trials and filing for U.S. Food and Drug Administration (FDA) approval of ORMD-0801, potentially the world’s first oral insulin capsule to reach the market.
Phase 3 Oral Insulin Trials: Top-Line Data Expected January 2023
ORA-D-013-1, the first of our two pivotal Phase 3 oral insulin trials for ORMD-0801 in the treatment of type 2 diabetes met and exceeded the number of planned participants, with 710 people enrolled. We expect to announce topline results in the next four weeks. ORA-D-013-2, our concurrent Phase 3 trial, continues to enroll the planned 450 patients, with enrollment expected to be completed in 2023.
Phase 2 NASH Trial Achieved Primary Endpoints
Our Phase 2 double-blind, randomized, placebo-controlled, multicenter clinical trial assessing the safety and efficacy of ORMD-0801 in the treatment of non-alcoholic steatohepatitis (“NASH”) in 32 patients with Type 2 diabetes and NASH achieved its primary endpoint of safety and tolerability, demonstrating consistent trends across key secondary endpoints with reduction of liver fat, liver stiffness and lipids. We believe ORMD-0801 may be an ideal treatment option for the millions of people living with both diabetes and NASH. We held a Key Opinion Leader webinar in November discussing the positive data and exciting potential of Oramed’s oral insulin candidate as a treatment option for this indication. The full webinar can be viewed on the Oramed website. There is currently no FDA approved treatment for NASH, which is expected to become an $84 billion market by 2029.
Definitive Deal with Medicox to Commercialize Oral Insulin in South Korea
Continuing to build global partnerships, we signed an exclusive commercial distribution agreement for South Korea with Medicox Co., Ltd. which will have the exclusive license to apply for regulatory approval and distribute ORMD-0801 for ten years in South Korea. Medicox will purchase ORMD-0801 at an agreed upon transfer price and will additionally pay Oramed up to $18 million in developmental milestones, $2 million of which has already been received by Oramed, and up to 15% royalties on gross sales in a large and growing diabetes market.
Phase 1 Oral COVID-19 Vaccine Trial Reported Positive Preliminary Data
Our subsidiary Oravax’s first cohort in its Phase 1 clinical trial of our oral virus-like particle (VLP) COVID-19 vaccine for COVID-naive participants achieved its primary and secondary endpoints of safety and immunogenicity based on preliminary data. Our oral vaccine elicited a potentially protective IgG response with significant seroconversion from baseline. We believe this trial shows proof of concept for oral delivery of vaccines using Oravax’s technology. Complete Phase 1 results are expected in the first quarter of 2023.
Oral GLP-1 Bioavailability Trial
ORMD-0901, our oral glucagon-like peptide-1 (GLP-1) analog capsule, is currently being evaluated under an FDA Investigational New Drug (IND) application and we expect to issue an update regarding the trial’s progress in the coming weeks. GLP-1 is an incretin hormone that stimulates the secretion of insulin from the pancreas. Exenatide, a GLP-1 analog, is currently available in injectable form only. An oral GLP-1 could significantly increase compliance and become a valuable tool in the treatment of diabetes.
We are entering 2023 with real excitement for what we believe will be a monumental year for the Company. We thank you, our shareholders, for your support and we thank our partners and trial volunteers for helping advance our clinical and other efforts. We wish you all a happy and healthy new year and look forward to keeping all our shareholders updated on news and developments.
Chief Executive Officer
About Oramed Pharmaceuticals
Oramed Pharmaceuticals (NASDAQ: ORMP) (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 is seeking to transform the treatment of diabetes through its proprietary lead candidate, ORMD-0801, which is being evaluated in two pivotal Phase 3 trials 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). Oramed has offices in the United States and Israel. 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 potential of ORMD-0801 to be the first commercial oral insulin capsule for the treatment of diabetes, the expected release of top-line data for ORA-D-013-1, the potential safety and efficacy of ORMD-0801 to treat diabetes and NASH, the expected market for drugs to treat NASH, the potential of ORMD-0801 to be a well-tolerated and convenient oral insulin product for the treatment of patients with diabetes and NASH, the potential development of an oral COVID-19 vaccine, the pace of studies and trials for such oral vaccine and the potential effectiveness, safety, immunogenicity and other advantages of the vaccine against current and future coronavirus strains or for the broader vaccines market, the potential for regulatory approval or development of ORMD-0801 in South Korea or elsewhere, potential future payments to Oramed from Medicox, including pursuant to milestone or royalty payments and expected updates regarding ORMD-0901. 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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SOURCE Oramed Pharmaceuticals Inc.