Oramed Submits Protocol To Initiate Phase 2a Trial Of ORMD 0801 - Quick Facts

(RTTNews) - Oramed Pharmaceuticals Inc. (ORMP) announced Monday that it has submitted a protocol to the U.S. Food and Drug Administration or FDA to initiate a Phase 2a trial of its orally ingestible insulin capsule, ORMD 0801, for type 1 diabetes.

The company stated that the protocol was submitted under its existing IND for ORMD-0801 to include both type 1 and type 2 diabetes indications. The double-blind, randomized, placebo controlled, seven-day study design will be carried out at an inpatient setting on twenty-four type 1 diabetic patients. It expects that US- based study will start later this quarter.

Oramed said it proposes to introduce ORMD-0801 to reduce the mealtime insulin doses, introducing a treatment regimen which would allow for fewer daily injections. Moreover, oral administration offers the benefit of reduced systemic exposure and may enable tighter regulation of blood sugar levels by directly affecting glucose control in the liver.