ORMP - Oramed's Chinese partner HTIT completes phase 3 oral insulin trial; submits marketing Application in China; stock Up 17%

2023-05-15 09:40:44 ET

• Oramed Pharmaceuticals ( NASDAQ: ORMP ) has announced the successful completion of Phase 3 trials for oral insulin in type 2 diabetes in China by its strategic partner, Hefei Tianhui Biotechnology (HTIT). The trials were conducted under a differentiated study protocol.
• ( ORMP ) has risen ~17% .
• HTIT is now progressing towards regulatory approval and has submitted the data to the National Medical Products Administration, the company said.
• Analysis reveals specific patient subpopulations, including BMI, baseline HbA1c, age, gender, and body weight, positively respond to oral insulin, showing over 1% placebo-adjusted reduction in HbA1c.
• The correlation between baseline BMI and positive outcomes in the U.S. Phase 3 trial aligns with encouraging data from the HTIT trial in China, where the baseline BMI was similar across populations .

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