Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company is about to start their Phase 3 Studies for their oral insulin candidate drug, ORMD-0801. The ORMD-0801 has the potential to better the lives of millions of diabetics around the world – allowing, amongst other things, type 2 patients to begin insulin therapy earlier without fear of needles.
According to guidelines received from the U.S. Food and Drug Administration (FDA) as part of the End-of-Phase 2 meeting process for ORMD-0801, ORAMED has submitted to the FDA the protocols for their upcoming pivotal Phase 3 studies. In line with the FDA’s recommendations, ORAMED intends to conduct two Phase 3 studies concurrently in patients with type 2 diabetes (T2D). These studies involve about 1,125 patients to provide evidence of ORMD-0801‘s safety and efficacy in T2D patients over a treatment period of 6 to 12 months. A geographically diverse patient population will be recruited from multiple sites throughout the U.S., European Union countries, and Israel.
The ORA-D-013-1 study will treat T2D patients with inadequate glycemic control who are currently on 1, 2 or 3 oral glucose-lowering agents. This U.S. study will recruit 675 patients from 75 clinical sites located throughout the U.S. Patients will be randomized 1:1:1 in this double-dummy study into cohorts of: 8 mg ORMD-0801 once-daily at night and placebo 45 mins before breakfast; 8 mg ORMD-0801 twice-daily, at night and 45 mins before breakfast; and placebo twice-daily, at night and 45 mins before breakfast. The primary endpoint of the study is to evaluate the efficacy of ORMD-0801 compared to placebo in improving glycemic control as assessed by A1c, with a secondary efficacy endpoint of assessing the change from baseline in fasting plasma glucose at 26 weeks.
The ORA-D-013-2 study will include T2D patients with inadequate glycemic control who are managing their condition with either diet alone or with diet and metformin monotherapy. A total of 450 patients will be recruited through 36 sites in the U.S. and 25 sites in Western Europe and Israel. Patients will be randomized 1:1 into two cohorts dosed with: 8 mg ORMD-0801 at night; and placebo at night. The primary endpoint is to evaluate the efficacy of ORMD-0801 compared to placebo in improving glycemic control as assessed by A1c over a 26-week treatment period, with a secondary efficacy endpoint of assessing the change from baseline in fasting plasma glucose at 26 weeks.
ORAMED plans to start recruiting patients for both studies this quarter and expects efficacy data to be available after all patients have completed the 6-month treatment period. If successful, ORAMED expects to conduct a pre-BLA (Biologics License Application) meeting to finalize the plans and data for the BLA submission. After BLA submission and review, if the BLA is approved, a full 12 years of marketing exclusivity would be granted.
“We are looking forward to our planned Phase 3 trial,” concludes Kidron. “We are additionally very pleased with the progress of our Chinese partners, HTIT, who will also be initiating Phase 3 trials for our oral insulin and might even become the first to reach commercialization.”
About Oramed Pharmaceuticals
ORMED 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. This POD technology is designed to protect orally delivered proteins from detrimental enzymatic activity within the gastrointestinal tract and to enhance their absorption across the intestinal wall. The active protein is placed in a capsule with a protective coating that remains intact in the most acidic segments of the gut. An absorption enhancer helps the protein pass across the intestinal barrier.
ORAMED is seeking to revolutionize the treatment of diabetes through its proprietary lead candidate, ORMD-0801, with the potential to be the first commercial oral insulin capsule for the treatment of diabetes. The Company has completed multiple Phase 2 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.
Contact Estee Yaari +1-844-9-ORAMED estee at oramed.com
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