Oramed announces that its Chinese partner, HTIT, has successfully completed a phase III oral insulin clinical trial and submitted a MAA in China.
Oramed Pharmaceuticals Inc. announced that Hefei Tianhui Biotechnology Co. Ltd. (HTIT), a strategic partner of Oramed, has successfully completed its Phase III 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).
Oramed has recently completed an analysis of the data from its U.S.-based, Phase III trial, ORA-D-013-1, for the treatment of type 2 diabetes ORA-D-013-1 trial which did not meet its endpoints. The 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 III 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.
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