Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, has completed patient enrollment for its Phase 3 ORA-D-013-1 study of its oral insulin capsule ORMD-0801 for the treatment of type 2 diabetes (T2D), surpassing its target of 675 patients with 710 patients enrolled. ORMD-0801 is positioned to potentially be the first FDA-approved oral insulin for the treatment of diabetes.
ORA-D-013-1 is the larger of Oramed‘s two Phase 3 studies being conducted under U.S. Food and Drug Administration (FDA) approved protocols to treat T2D patients who have inadequate glycemic control over a period of 6 to 12 months. Efficacy data for ORA-D-013-1 will become available after all patients have completed the first 6-month treatment period.
Type 2 diabetes (T2DM) is a progressive disease characterized by impaired ß cell function and insulin resistance. There are over 460 million type 2 diabetics worldwide with an economic burden of more than half a trillion dollars annually! Oramed’s oral insulin (ORMD-0801) has the potential of improving the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment, potentially slowing disease progression and delaying or even eliminating late-stage complications.
“We are thrilled to announce that the world’s first Phase 3 oral insulin study, conducted under an FDA protocol, has achieved a significant milestone with the completion of enrollment. Following the last patient’s six months of treatment, we anticipate announcing topline results in January 2023,” said Oramed CEO Nadav Kidron. “We are very excited about the prospect of an oral insulin option for people living with diabetes. Being delivered orally, oral insulin mimics endogenous insulin regulation before reaching the bloodstream, providing better blood glucose control and potentially reducing risks and complications associated with injectable insulin, including weight gain and hypoglycemia, while also being easier to administer. I would like to thank all of the patients, investigators, and partners involved in this clinical trial, all with the common goal of bringing forth a breakthrough in diabetes therapy.”
Oramed’s oral insulin capsule (ORMD-0801) is also anticipated for use as a complementary agent to insulin injections in the treatment of T1DM. This treatment regimen should allow for fewer daily injections and a lower frequency of blood glucose fluctuations in cases of unstable and brittle T1DM. Type I diabetes mellitus (T1DM), also known as insulin-dependent diabetes, is an autoimmune disease where the immune system attacks and destroys pancreatic ß cells. Hence little or no insulin is produced to facilitate the uptake of glucose. Clinically, T1DM is marked by fluctuations in glycemic readings and poor glycemic control.
About the ORA-D-013-1 Study
The ORA-D-013-1 study initially aimed to enroll 675 patients and has now completed its enrollment oversubscribed with a total of 710 patients. The enrolled patients are currently on 2 or 3 oral glucose-lowering agents through 96 clinical sites throughout the U.S. The primary endpoint of the study is to compare the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by A1c, with a secondary endpoint of assessing the change from baseline in fasting plasma glucose at 26 weeks. Efficacy data will become available after all patients have completed the first 6-month treatment period.
More information can be found here: ORA-D-013-1.
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 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). Glucagon-like peptide-1 (GLP-1) is an incretin hormone that stimulates the secretion of insulin from the pancreas. Exenatide, a GLP-1 analog, is currently marketed in injectable form and is indicated for the treatment of type 2 diabetes. Exenatide induces insulin release at increased glucose levels and causes a feeling of satiety, which results in reduced food intake and weight loss.
For more information, please visit www.oramed.com
Source: PRNEWSWIRE.COM May 3, 2022
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