Oramed "Positive Outlook on Oral Insulin Phase 3 Clinical Trial Results"

Nadav Kidron, CEO of Oramed. / Photo by Medicox

[Asia Economy Reporter Jang Hyowon] MedicoX, a KOSDAQ-listed company, has an exclusive distribution agreement with Israeli pharmaceutical company Oramed Pharmaceuticals, which expects positive results from the Phase 3 clinical trial of its oral insulin to be announced in mid-January.

Nadav Kidron, CEO of Oramed, held a briefing on the “Oral Insulin Capsule (ORMD0801) Clinical Status” on the 29th at the Chosun Palace Hotel Seoul Gangnam with MedicoX, stating, “The Phase 3 clinical trial results will be announced in January, and we expect the results to be the same as those of Phase 2.”

Oramed is developing the oral insulin candidate ‘ORMD-0801’ and conducting clinical research. Insulin therapy is essential for diabetes patients. Diabetes is a disease in which the body has problems secreting insulin necessary for blood sugar regulation, causing abnormal increases in blood sugar levels.

Diabetes patients inject insulin at regular intervals. In contrast, Oramed’s oral insulin allows blood sugar control through a pill, reducing patients’ discomfort. Additionally, since insulin is not administered directly into the bloodstream but works naturally in the liver, side effects such as weight gain are minimal.

Currently, Oramed is conducting two Phase 3 clinical trials. Michael Rabinovitz, COO of Oramed, said, “In the Phase 2b clinical trial involving 298 patients with type 2 diabetes, HbA1c levels significantly decreased, and no serious adverse reactions were observed. We plan to announce the 26-week data from the Phase 3 clinical trial results in January, and we expect these results to be consistent with those of Phase 2b.”

MedicoX CEO Oh Daehwan stated, “If the oral insulin receives approval from the U.S. Food and Drug Administration (FDA), MedicoX will be responsible for domestic approval and all clinical-related tasks,” adding, “We are pursuing business diversification for the pharmaceutical and bio industries, which are the most promising sectors in the future industry.”

Meanwhile, the event was attended by Oramed CEO Nadav Kidron, CCO Michael Rabinovitz, Oramed executives, MedicoX CEO Oh Daehwan and staff, and Akiva Tor, the Israeli Ambassador to Korea, among others.