Oramed's oral insulin shines in mid-stage trials
- In a 28-day clinical study involving 180 patients with type 2 diabetes (T2DM), Oramed significantly reduced nocturnal hypoglycemia.
- ORMD-0181 is Oramed's oral insulin in development. The goal of using ORMD-0181 to treat patients with T2DM is to reduce excessive nocturnal glucose production from the liver. For patients with type 1 diabetes (T1DM), the goal is to use oral insulin, in addition to injectable insulin, with the goal of decreasing the number of injections a patient needs on a daily basis.
- Oramed is going after indications for both T1DM and T2DM with ORMD-0181. Of the 400 million people worldwide with diabetes, 90% of them have T2DM.
Creating a safe, effective, tolerable oral insulin has become the holy grail of diabetes drug development, and Israel-based Oramed is one of the frontrunners in this race, along with Novo Nordisk.
In Oramed's phase 2 study, the patients enrolled in the trial were uncontrolled despite treatment with metformin, one of the cornerstones of treatment in T2DM patients. In patients treated with ORMD-0181, there was a 6.5% reduction in nocturnal NG versus placebo.
Last year, BioPharma Dive spoke with Josh Hexter, chief operating officer of Oramed, who explained: “Our oral insulin is not a substitute for insulin injections, but rather a new, earlier treatment option.”
In other words, the introduction of an oral insulin has the potential to improve long-term outcomes for patients with diabetes. Market research shows that the global insulin market will reach roughly $47 billion by 2020, up from $20 billion in 2013.