Last Patient Treated in Pivotal Trial of Oral Insulin Candidate

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By : dLife Editors

Oramed Pharmaceuticals Inc., a pharmaceutical company developing oral drug delivery systems, announced the treatment of the last patient in the primary cohort of the Phase IIb HbA1c trial last month.

The trial evaluates Oramed’s lead oral insulin candidate, ORMD-0801, which has the potential to be the first commercial oral insulin capsule for the treatment of Type 2 diabetes.

The Phase IIb double-blind, randomized, 90-day dose-ranging trial will assess the primary efficacy endpoint of reduction in HbA1c, as well as safety endpoints.

Topline data from the primary cohort of the Phase IIb trial are expected to be released in the fourth quarter of 2019.

“Our lead oral insulin program could be a major advancement for the diabetes community as we believe it should offer a healthier way to treat diabetes,” said Nadav Kidron, Oramed chief executive officer. “With the last patient out in this pivotal trial, we have positioned ourselves as the leader in the clinical development of oral insulin.”

Oramed has completed multiple Phase II clinical trials under an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA).

In addition, Oramed is developing an oral GLP-1 (Glucagon-like peptide-1) analog capsule, ORMD-0901, which has the potential to be the first orally-ingestible GLP-1 analog.

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  1. Oramed Pharmaceuticals. (2019, September 17). Oramed Announces Last Patient Treated in Pivotal Phase IIb Trial of Oral Insulin ORMD-0801PR Newswire. Retrieved October 24, 2019, from