Oramed Pharmaceuticals, a developer of oral delivery systems, successfully completed a comprehensive toxicity study for its flagship oral insulin capsule, ORMD-0801. The study was completed under conditions prescribed by the FDA’s Good Laboratory Practices regulations and is the last study required before an IND filing.
Three groups comprised of 30 rats each were orally administered a once-daily, fixed-dose of one of three ORMD-0801 formulations for 28 days. In parallel, three independent groups of identical sizes received various control formulations to ensure the safety of all applied exipients. Exipient doses in the assessed formulations were up to three times those used in ORMD-0801 capsules tested in clinical trials to date. Ten animals of each treatment group were monitored throughout an additional 14-day post-treatment recovery period.
At the end of the respective monitoring periods, blood samples of all animals were measured for hematological, blood clotting, clinical chemistry and urinalaysis parameters, while ophthalmic, body and organ weight changes were also recorded. Food consumption and animal survival were followed throughout the study period. No mortality, adverse effects or changes in the evaluated parameters were observed throughout the treatment and recovery periods for any of the active or control test items.