– Recruiting and Dosing Patients Across Growing Number of U.S. Sites in Phase 3 Oral Insulin Trial
– Clinical Advancements in NASH & Leptin
– Discussions with Potential Partners Under Way
– To view a video message from the CEO, click here
NEW YORK, Jan. 27, 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 technology, is pleased to provide the following Letter to Shareholders from Chief Executive Officer Nadav Kidron.
We begin 2021 with new hope as vaccines and treatments essential to returning our global community to a new, and better normal are rolling out. During 2021, we are focused on achieving significant advancements with the world’s first pivotal Phase 3 oral insulin trial conducted through an FDA approved protocol. We’re excited by the progress being made in bringing oral insulin to fruition.
Phase 3 Oral Insulin: Enrolling and Randomizing Patients
The FDA approved Oramed’s two double blind, placebo controlled, multicenter protocols which will evaluate our oral insulin (ORMD-0801) in type 2 diabetes (T2D) as follows:
- ORA-013-1: Evaluation of efficacy and safety of ORMD-0801 in 675 subjects in the U.S. who have inadequate glycemic control and are currently taking two or three oral glucose-lowering agents
- ORA-013-2: Evaluation of efficacy and safety of ORMD-0801 in 450 subjects in the U.S., Europe, and Israel who have inadequate glycemic control and are on diet modification without medication, or on metformin monotherapy
In November 2020, we initiated screening patients for ORA-013-1, and we continue to screen and randomize patients at a growing number of sites in the United States, making ORMD-0801 the first insulin capsule to enter Phase 3 trials in the U.S. under an FDA approved protocol. We look forward to sharing recruitment numbers later in Q1 2021 and plan to provide updates as we reach enrollment milestones.
Efficacy data from the trials will become available after patients have completed the first 6 months of treatment. Safety will be further monitored as patients will be exposed to the drug over an additional 6 months. The trial’s topline results are expected in 2022.
Oral Insulin: NASH Phase 2 Initiated
We are enrolling patients in our global Phase 2 nonalcoholic steatohepatitis (NASH) study which was initiated in December 2020 when the first patients were screened in the U.S. Additional clinical sites in Europe and Israel are expected to begin recruitment later in Q1 2021. The trial will measure efficacy endpoints via MRI- derived proton density fat fraction (MRI-PDFF) for 12 weeks, as well as percent change in liver fibrosis and liver steatosis. We anticipate completing this NASH study in 2021.
Data from our pilot study of ORMD-0801 in diabetic patients with NASH showed impressive results, including a 30% relative reduction in fatty liver content, as measured by MRI-PDFF. Gamma-glutamyltransferase (GGT), a key marker of chronic hepatitis, and fasting insulin levels were both significantly lower after 12 weeks of treatment as compared to baseline. The study found ORMD-0801 was safe and well tolerated in this patient population.
Oral GLP-1 and Leptin: Additional Studies Expected in 2021
This year we anticipate initiating a bioavailability study for ORMD-0901, our oral glucagon-like peptide-1 (GLP-1) analog capsule, in T2D patients. A prior Phase 1 pharmacokinetic (PK) study showed ORMD-0901, in healthy volunteers, preserved the biological activity of orally delivered GLP-1 and curbed blood sugar excursions following glucose challenge. An effective GLP-1 analog, in addition to decreasing blood glucose levels, can also reduce HbA1c, preserve beta cell function, and promote weight loss.
In 2020, we conducted an exploratory oral leptin trial to evaluate glucagon reduction in type 1 diabetes (T1D). Leptin is a protein that regulates hunger and is of interest to us as a potential addition to our clinical development platform. The proof-of-concept study evaluated the pharmacokinetic and pharmacodynamics of our oral leptin drug candidate in adult T1D patients and showed that patients who received leptin, on average, had a decrease in glucose as compared to the placebo group during the first 30-180 minutes following dosing. We anticipate initiating a larger double-blind, placebo-controlled study for our oral leptin capsule later this year.
I am pleased to confirm that we entered 2021 with a strong balance sheet and solid financial position which allows us to move forward on all fronts. From this position of strength, we are holding discussions with potential partners and collaborators across the globe.
All of us at Oramed wish you and yours good health.
Chief Executive Officer
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, with offices in New York and Israel, Oramed has developed a novel Protein Oral Delivery (POD™) technology. Oramed is seeking to revolutionize 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 expected recruitment and enrollment for our trials and studies, the expected timing of initiating and completing our trials and studies, the potential for FDA approval of our oral insulin, our expectation that we have enough cash to move forward, expected updates regarding future milestones, potential safety and toleration and efficacy of ORMD-801, the validation of preliminary findings in future trials, discussions with potential partners and collaborators, the potential of ORMD-0801 to be the first commercial oral insulin capsule for the treatment of diabetes or revolutionizing the treatment of diabetes with our products. 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.
+1-844-9-ORAMED Ext: 2
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SOURCE Oramed Pharmaceuticals Inc.