ORMD-0801 dosed once daily reduced A1C by 0.60% compared to only a 0.06% reduction by placebo
ORMD-0801 improves metabolic control as evidenced by significant reduction in A1C levels in patients with type 2 diabetes inadequately controlled on multiple other standard of care drugs
NEW YORK, Nov. 19, 2019 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (ORMP) (ORMP.TA) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, conducted an investor event and conference call yesterday, November 18, 2019, where a panel of investigators and Key Opinion Leaders presented detailed findings from the Company's successful Phase IIb study of ORMD-0801 in the treatment of type 2 diabetes.
Panelists presenting the data included: Dr. Joel Neutel, Principal Investigator of the study and Director of Research at Orange County Research Center; Kenneth Homer, the trial's biostatistician; Dr. Ramachandra Naik, Professor of Medicine/Endocrinology at SUNY Upstate Medical University; and Dr. Alexander Fleming, CEO of Kinexum, and former Head of Clinical Review of Endocrine and Metabolic Drugs at the U.S. Food and Drug Administration (FDA).
Key highlights from the investor event included the following:
Comments by Dr. Naik:
- ORMD-0801 has the potential to be used as a second, third, and fourth line oral agent for the treatment of type 2 diabetes. The Phase IIb data has shown efficacy in patients whose diabetes was inadequately controlled either on metformin alone, or metformin with up to two additional oral antihyperglycemic agents, with the latter group constituting the majority.
- Being on multiple antihyperglycemic agents implies that patients are in more advanced stage in the natural history of the disease and it is noteworthy that ORMD-0801 had a statistically significant and clinically meaningful benefit in those patients.
- The glycemic efficacy along with reassuring safety profile, support a unique mechanism of action of ORMD-0801, namely, replication of normal physiology of insulin secretion and absorption through the portal vein followed by direct delivery to the liver leading to an effective treatment with less risk of hypoglycemia and weight gain.
Comments by Dr. Fleming:
- ORMD-0801 demonstrated an excellent safety profile, specifically with regards to hypoglycemic events as compared to other insulin products on the market today, for which hypoglycemia is a major risk.
- Dosing at night addresses a major challenge of type 2 diabetes: People with the disease generally awake in the morning at a metabolic disadvantage. By improving night-time glucose levels, a person with diabetes can start the day with improved metabolic condition, which enables better control of blood glucose levels throughout the day.
- The key advantage of Oramed's oral insulin is its ability to safely deliver insulin in a more physiologic manner. While convenience is a benefit of oral administration, the most important benefit by far is a safer way to give insulin therapy.
Comments by Dr. Neutel:
- The goal of this Phase IIb study was to gather information for next year's anticipated Phase III trial.
- The primary endpoint, reduction in HbA1c compared to placebo at week 12, was achieved. 32mg of ORMD-0801 administered orally once a day demonstrated a reduction of 0.54, after adjusting for placebo, with a statistically significant p-value of 0.036.
- Significant safety outcomes included no increase in adverse events when compared to placebo, no increase in hypoglycemic events when compared to placebo, and no weight gain when compared to placebo.
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 (PODTM) technology that is based on more than 30 years of research by scientists at Jerusalem's Hadassah Medical Center. 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 Type 2 and Type 1 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, which has potential to be the first orally-ingestible GLP-1 analog.
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 safety and efficacy of ORMD-0801, the ability of ORMD-0801 to reduce HbA1c, the potential uses and advantages of ORMD-0801 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.