While the entire 2020 was a nightmare to the global population, the Covid-19 vaccines have definitely been able to at least pave the path to recovery from the pandemic – most possibly within the next few months. But here is fantastic news for those millions of diabetic patients around the world. According to media reports, nearly half-a-billion of diabetic patients, who have eventually no other option but to use insulin injection – until now – will be soon relieved of this painful process, as one Israeli company took a huge step towards a much-anticipated alternative – an insulin capsule – which also is known as oral insulin.
While many of the huge pharmaceutical corporations have spent millions of dollars trying to create an oral insulin pill, none have succeeded so far, Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, just announced unprecedented topline data from the second and final cohort of its Phase 2b trial evaluating the efficacy and safety, at lower dose regimens, of its lead oral insulin capsule, ORMD-0801.
According to medical experts, this new development, which signals the first commercial oral insulin capsule for the treatment of type 2 and type 1 diabetes, might be the game-changer that revolutionizes the treatment of diabetes.
Established in 2006, with offices in the US and Israel, Oramed has developed a Protein Oral Delivery technology that is based on more than 30 years of research by scientists at Jerusalem’s world-famous Hadassah Medical Center.
Since insulin was first discovered, it has been impossible to deliver it orally, because of degradation and factors affecting absorbance; since insulin is a protein, the body breaks it down when ingested. The company uses enteric coating and special protection which allows the insulin to stay intact through the GI tract and reach the intestinal wall. Via special absorption enhancers, the insulin can pass through this wall and into the liver, where it starts working. Importantly, it mimics the natural path of insulin in the body, by heading to the liver first.
Although diabetes has spread rapidly, the average person knows very little about living with this chronic condition. In addition to pain, inconvenience, visible scars and dependence, many patients living with diabetes simply cannot afford to keep up with the rising costs of insulin. According to one Washington Post report, because of the skyrocketing prices of insulin, some desperate diabetics are rationing the drug and putting their lives at risk as a result.
Researchers also found that many diabetes patients were cutting back on insulin due to its high cost. Other studies estimate that at least 25 percent of patients with diabetes are not taking the insulin prescribed to them.
Oramed CEO Nadav Kidron is confident that the cost of the pill will be significantly lower (by tens of percent) than the cost of insulin injections.
In addition, treatment with the capsule at all doses demonstrated an excellent safety profile, with no serious drug-related adverse events and no increased frequency of hypoglycemic episodes or weight gain, compared to placebo.
According to Nadav Kidron, Oramed Pharmaceuticals is already discussing with the FDA for its planned Phase-3 trial while they additionally are very pleased with the progress of Oramed’s Chinese partners, HTIT, who will also be initiating Phase-3 trials for its oral insulin and “might even become the first to reach commercialization”.
Commenting on the success of Oramed Pharmaceutical’s diabetic oral insulin, Sazzad Ahmed, CEO of SUSCO, a Bangladeshi company said: “For years, we are maintaining communications with Oramed Pharmaceuticals with the hope of marketing their oral insulin in this country”.
He said, “The size of diabetic patients in Bangladesh is huge, and for them, Oramed’s invention certainly is excellent news for them. We also are delighted knowing from Mr. Nadav Kidron that the cost of the pill will be significantly lower (by tens of percent) than the cost of insulin injections”.