Oramed Pharmaceuticals Inc. announced the completion of patient enrolment in the phase 2B clinical study of its oral insulin capsule, ORMD-0801. The last of the thirty Type II diabetes patients was enrolled for a study in which subjects will be administered the insulin-based capsule for a period of six weeks.
The randomized, double-blind, placebo-controlled, multi-centred study will evaluate the safety, tolerability, and efficacy of Oramed’s oral insulin delivery technology. The study is taking place in five locations throughout South Africa and is being monitored by OnQ Consulting, a clinical research organization (CRO) based in Johannesburg, South Africa. Study results are expected by the end of first quarter of 2010.
This trial marks an important milestone in ORMD-0801 safety testing, assessing the first indication of ORMD-0801 on a large group of volunteers over an extended treatment period.
“The closing of enrolment for the phase 2B trial is an exciting accomplishment for us, as it moves us closer to completing this trial and receiving the results. In the upcoming months, we look forward to being able to share the results from the trial, which will mark a major milestone in the development of oral insulin”, explained Nadav Kidron, CEO of Oramed Pharmaceuticals.
Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs and vaccines presently delivered via injection. Oramed is seeking to revolutionize the treatment of diabetes through its patented flagship product, an orally ingestible insulin capsule currently in phase 2 clinical trials.