Oramed Pharmaceuticals Inc. (Nasdaq/TASE: ORMP), a clinical-stage pharmaceutical company dedicated to the development of oral drug delivery systems, has released the top-line results of its Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical trial (ORA-D-013-1). This trial examined the efficacy of ORMD-0801 versus placebo in patients with Type 2 Diabetes (T2D) and inadequate glycemic control on two or three oral glucose-lowering agents over the course of 26 weeks. The trial involved 710 participants and was an exciting step in Oramed’s mission to revolutionize the way we treat T2D.
The ORA-D-013-1 trial, comparing the efficacy of ORMD-0801 to placebo in improving glycemic control, failed to reach its primary and secondary endpoints. No serious drug-related adverse events were reported, leading Oramed to discontinue its oral insulin clinical activities for those with Type 2 diabetes. Unfortunately, the trial was unable to demonstrate the hoped-for improvements in A1C and fasting plasma glucose at the 26-week mark.
We are deeply disappointed with today’s outcome, especially given the successful outcomes of our prior trials. Once all the data is available, we will share our insights and future plans. We are immensely grateful to the patients, families and healthcare professionals who took part in the study. Oramed’s Chief Executive Officer, Nadav Kidron, expressed his appreciation.
Additional Information About the ORA-D-013-1 Phase 3 Clinical Trial
The ORA-D-013-1 trial tested the efficacy of 8mg of a certain drug, either dosed once-daily or twice-daily, against a placebo. Over the course of the trial, which included a 21-day Screening Period and a 26-week Double-Blind Treatment Period, patients were randomized 2:2:1:1 into four groups. Find out more about this exciting trial here: ORA-D-013-1.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is revolutionizing the way drugs are delivered to patients! Their innovative Protein Oral Delivery (POD™) technology is designed to protect drug integrity and increase absorption, making it possible for drugs previously only available via injection to be taken orally. With offices in both the US and Israel, Oramed is at the forefront of the industry and leading the charge in the advancement of drug delivery solutions.
Oramed is committed to providing updates on its future strategy, plans and prospects, as well as additional analyses of clinical and business activities. However, our progress is subject to a number of risks and uncertainties that could affect our ability to successfully implement our plans. These include the progress, timing, cost and results of our current and future clinical trials and product development programmes, potential competition, and the need for additional funding. In addition, there are other potential risks such as changes in technology, legislation, and the acceptance of our methods by the scientific community, which could all have an impact on our results. We therefore urge caution when interpreting our progress and urge readers to refer to our most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission for a detailed description of the risks and uncertainties that may affect Oramed.