1 in 10 people worldwide struggle with diabetes, with Type 2 dominating at 90%. Unfortunately, for many, managing blood sugar becomes a complex battle. While lifestyle changes and medications like metformin are the first line of defense, insulin injections often stand as the final weapon, dreaded for their pain, stigma, and potential side effects like weight gain and hypoglycemia.
Oramed, backed by the EU's Oralis project, saw a brighter future. Instead of painful injections, their goal: an oral insulin that bypasses the bloodstream and targets the liver, where it can do its job naturally.
Years of research led to a groundbreaking technology. Imagine a tiny insulin-carrying capsule. Its secret weapon? A special coating that shields it from the digestive tract's harsh environment. Next, imagine protein-fighting allies called protease inhibitors, standing guard against gut enzymes that would otherwise dismantle the insulin. Finally, picture absorption enhancers, like tiny ladders, helping the insulin scale the intestinal wall and reach its destination.
This unique combination, the brainchild of Oramed's dedication, could revolutionize diabetes treatment. No more needles, no more fear. Just a simple pill, paving the way for better blood sugar control and potentially saving lives.
This new twist on an old problem brings hope to millions. While more research is needed, Oramed's oral insulin stands as a beacon of a future where diabetes management is a little less daunting, a little less painful, and a whole lot more empowering. Below is a recent clinical study on ORMD-0801.
This study investigated the safety and effectiveness of a new oral insulin,
ORMD-0801, in improving blood sugar control for people with uncontrolled type 2 diabetes. Over 370 participants received either ORMD-0801 at various doses and frequencies or a placebo for 12 weeks.
The key findings:
- Improved blood sugar control: Compared to placebo, ORMD-0801 at specific doses significantly lowered HbA1c, a measure of long-term blood sugar levels. This was most evident with 8mg taken once daily or twice daily, reducing HbA1c by approximately 0.65%.
- Safe and well-tolerated: ORMD-0801 was safe and did not cause weight gain or frequent low blood sugar (hypoglycemia).
- Continued development: Based on these results,
researchers are further investigating the 8mg bedtime dose as a
promising option for managing uncontrolled type 2 diabetes in larger
Phase 3 studies.
This study suggests that ORMD-0801 could offer a convenient and effective treatment option for people with type 2 diabetes who struggle to control their blood sugar with current medications. Larger trials are needed to confirm the results, its long-term benefits and safety.
US Patents / Patent Applications
Oramed is the assignee for 31 US patents / applications. The key inventors for these patents/applications are Ramesh N Acharya and Miriam Kidron.
Oramed's patented technology starts with "a polymeric controlled release composition comprising a reaction complex
formed by a calcium polycarbophil component." (US5102666A), then an oral pharmaceutical composition comprising a recombinant protein, a first protease inhibitor,
and a second protease inhibitor, wherein each of said first protease
inhibitor and said second protease inhibitor inhibits trypsin. (Miriam Kidron; US-20110014247-A1)
Reference:
Roy Eldor et al, Oral insulin (ORMD-0801) in type 2 diabetes mellitus: A dose-finding 12-week randomized placebo-controlled study, Diabetes Obes Metab. 2023 Apr;25(4):943-952
Oralis, The first oral human insulin treatment for Type 2 Diabetes Mellitus, Cordis, EU research results, European Commission, August 17, 2022
