Israeli company Oramed Pharmaceuticals, a clinical-stage pharmaceutical company focused on the development of oral drug delivery technology, has issued the following letter to its shareholders. The letter was signed by Mr. Nadav Kidron, Chief Executive Officer of Oramed.
In the letter, Mr. Kidron wrote:
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-glutamyl transferase (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.
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.