Therapy Areas: Diabetes
Oramed's Second Phase 3 Oral Insulin Trial reaches 50% enrolment
27 July 2022 -

Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP), an Israel-based clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, announced on Tuesday that it has enrolled and randomised more than 50% of the planned 450 patients for its international multicentre Phase three ORA-D-013-2 trial of its oral insulin capsule, ORMD-0801, intended to treat type 2 diabetes (T2D).

The product is the second of the company's two Phase three trials being carried out under the United States Food and Drug Administration (FDA) Investigational New Drug Application (IND) to treat T2D patients who have inadequate glycaemic control over a period of six to 12 months.

The ORA-D-013-2 trial is recruiting 450 T2D patients with inadequate glycaemic control who are managing their condition with either diet alone or with diet and metformin monotherapy. The double-blind trial will randomise patients 1:1 into two cohorts dosed with 8mg of ORMD-0801 at night or placebo at night. The primary endpoint of the trial is to compare the efficacy of ORMD-0801 to placebo in improving glycaemic control as assessed by A1c over a 26-week treatment period, with a secondary endpoint of comparing ORMD-0801 to placebo in maintaining glycaemic control over a 52-week treatment period.



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