Hefei Tianhui Biotechnology (HTIT), a strategic partner of Oramed Pharmaceuticals, has completed its Phase III trials of oral insulin for type 2 diabetes in China and is seeking marketing approval.
HTIT has submitted the Phase III trial data through a marketing authorisation application to the National Medical Products Administration.
Oramed’s US-based ORA-D-013-1 Phase III trial for the treatment of type 2 diabetes showed significant lowering of A1C levels in patient subgroups.
Pooled specific parameters such as body mass index (BMI), baseline HbA1c, age, gender and body weight analysed in subpopulations of patients responded well to oral insulin.
The subsets also exhibited a statistically significant reduction in HbA1c.
In addition, the US subpopulation and the Chinese general trial population shared a very similar baseline BMI.
Oramed CEO Nadav Kidron said: “We are excited by our partner, HTIT’s, success and share in their excitement as they move one step closer to commercialisation in China.
“Additionally, we are encouraged by the review of our Phase III 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.”
Last March, Oramed Pharmaceuticals concluded subject enrolment in a Phase II clinical trial of its oral insulin capsule, ORMD-0801, to treat non-alcoholic steatohepatitis (NASH).
NASH is a severe and progressive liver disease and is caused by fat accumulation in the liver and accompanied by liver cell destruction, inflammation and liver scarring in certain cases.