Press release
Oramed Announces that its Chinese Partner, HTIT, has Successfully Completed a Phase 3 Oral Insulin Clinical Trial and Submitted a Marketing Authorization Application in China
Oramed has completed an analysis of its U.S.-based Phase 3 oral insulin trial with significant lowering of A1C levels seen in patient subgroups NEW YORK, May
About this update from Oramed Pharmaceuticals Inc.
[{"type":"text","content":"Oramed has completed an analysis of its U.S.-based Phase 3 oral insulin trial with significant lowering of A1C levels seen in patient subgroups\nNEW YORK, May 15, 2023 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com) announced today that Hefei Tianhui Biotechnology Co. Ltd. (HTIT), a strategic partner of Oramed, has successfully completed its Phase 3 trials of oral insulin in type 2 diabetes in China under a differentiated study protocol. HTIT is now moving toward regulatory approval and has submitted the data to the National Medical Products Administration (NMPA, formerly the CFDA).\n\n \n \n \n \n \n \n\n \nOramed has recently completed an analysis of the data from its U.S.-based, Phase 3 trial, ORA-D-013-1, for the treatment of type 2 diabetes. This analysis found that subpopulations of patients with pooled specific parameters, such as body mass index (BMI), baseline HbA1c, age, gender and body weight, responded well to oral insulin. These subsets exhibited an over 1% placebo adjusted, statistically significant, reduction in HbA1c. The significant impact of baseline BMI on the responder group within the U.S. Phase 3 trial aligns with the positive data from the HTIT trial in China. The U.S. subpopulation and the Chinese general trial population shared a very similar baseline BMI.\n\"We are excited by our partner, HTIT's, success and share in their excitement as they move one step closer to commercialization in China,\" said Oramed Chief Executive Officer, Nadav Kidron. \"Additionally, we are encouraged by the review of our Phase 3 data which found a strong correlation between certain parameters and the oral insulin's efficacy. Based on these findings, Oramed is exploring ways to move forward with its oral insulin product,\" Mr. Kidron added.\nAbout Oramed Pharmaceuticals \nOramed Pharmaceuticals (Nasdaq: ORMP) (TASE: ORMP) is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. The Company's novel Protein Oral Delivery (POD™) technology is designed to protect drug integrity and increase absorption. Oramed has offices in the United States and Israel. For more information, please visit www.oramed.com. \nAbout the Methodology Used for US Phase 3 Data Analysis\nOramed applied two separate methodologies to retrospectively analyze t...