Oramed Pharma (ORMP) Begins Second Phase 3 Oral Insulin Study Under FDA's Approved Dual Concurrent Protocol

March 23, 2021 9:00 AM EDT

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Oramed Pharmaceuticals Inc. (NASDAQ: ORMP), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today it has screened the first patients in its ORA-D-013-2 study, the second of two concurrent Phase 3 studies of its oral insulin capsule, ORMD-0801, for the treatment of type 2 diabetes (T2D).

The studies are taking place under U.S. Food and Drug Administration (FDA) approved protocols to treat T2D patients who have inadequate glycemic control over a period of 6 to 12 months. [Enrollment for the other Phase 3 study, ORA-D-013-1, is ongoing and has surpassed 25%]. The double-blinded, placebo-controlled, multi-center randomized studies will recruit a total of 1,125 patients to evaluate the efficacy and safety of ORMD-0801. Efficacy data for the studies will become available after all patients have completed the first 6-month treatment period.

"With both concurrent Phase 3 studies now enrolling, we have achieved another world-first milestone, as the only company to conduct two Phase 3 oral insulin studies under an FDA protocol. While ORA-D-013-1 will help us evaluate our oral insulin capsule in patients who are already on two or three glucose-lowering medications, ORA-D-013-2 will help us assess our oral insulin capsule in patients who are on diet control alone or on diet and metformin monotherapy. Evaluating ORMD-0801 in these diverse population groups is expected to yield compelling results for use cases upon potential approval," stated Oramed CEO Nadav Kidron.



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