Oramed submits protocol to FDA for phase IIb trial for oral insulin capsule
Israeli company set to change treatment for diabetes; largest study to date with over 30 clinical sites in the US to participate.
Oramed Pharmaceuticals hope to revolutionize treatment of diabetes with an oral insulin capsule. (Photo: Courtesy of Oramed Pharmaceuticals)
Israeli oral drug delivery specialist, Oramed Pharmaceuticals, has taken another step closer to the world’s first insulin pill when it announced this week that it has submitted the study protocol for the company’s Phase IIb trial of ORMD-0801, to the US Food and Drug Administration (FDA).
ORMD-0801 is the company’s proprietary flagship product, an orally ingestible insulin capsule. Upon FDA approval, it will revolutionize the treatment of diabetes.
The Phase IIb study of ORMD-0801 for type 2 diabetics is designed to generate ample data for both efficacy and safety endpoints.
The double-blind, randomized study will recruit approximately 180 patients and has a 28-day treatment period.
The study has already received Institutional Review Board (IRB) approval and patient enrollment is expected to start in the short term, the company says in a statement.
Oramed Pharmaceuticals’ technology is based on over 30 years of research by top scientists at Jerusalem’s Hadassah Medical Center. The company is considered a technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection.
Tune in to ISRAEL21c’s radio interview with Nadav Kidron, CEO of Oramed Pharmaceuticals, here.
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