You are currently viewing Oramed’s Chinese Partner, HTIT, Successfully Completes Phase 3 Oral Insulin Clinical Trial/Submits Marketing Authorization Application in China

Oramed Pharmaceuticals. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com) strategic partner, Hefei Tianhui Biotechnology (HTIT), 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 authorization application to the National Medical Products Administration, (NMPA, formerly the CFDA).
Oramed’s US-based ORA-D-013-1 Phase III trial for the treatment of type 2 diabetes showed a significant lowering of A1C levels in patient subgroups.

Pooled-specific parameters such as body mass index (BMI), baseline HbA1c, age, gender and body weight analyzed in subpopulations of patients responded well to oral insulin. Patients over 54 of age with a BMI of less than 31 tend to have the largest reduction in A1c p-value lower than 0.002.
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 commercialization 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.”

About Oramed Pharmaceuticals

Oramed 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.

Company Contact:
Zach Herschfus+1-844-9-ORAMED
zach AT oramed.com

 

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