Nearly half a billion people worldwide suffer from diabetes.
Many will eventually have no other option but to use insulin. Until now, insulin was only available via injection or an inhaler. One company just took a huge step towards a much-anticipated alternative: an Insulin capsule.
Oramed Pharmaceuticals Inc. (Nasdaq/TASE: ORMP), 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.
While many huge corporations have spent millions of dollars trying to create an oral insulin pill, none have succeeded so far. 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 New York 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 Hadassah Medical Center.
The options of diabetics.
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.
Nadav Kidron, Oramed CEO.
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. “The statistically significant efficacy data,” says Joel M. Neutel, MD, Principal Investigator of the Phase 2b trial, “coupled with a clean safety profile characterized by no reported weight gain, no increase in serious drug-related adverse events, and no hypoglycemia, further support its clinical potential. It further validates the clinical potential of oral insulin to have a highly beneficial impact on the treatment of diabetes worldwide.”
A1C levels are a key indicator of diabetes. In this latest trial, patients who were treated with 8 mg of the capsule once daily achieved an observed mean reduction of 1.29% from the baseline and a least square mean reduction of 0.95% from baseline (0.81% placebo adjusted). Patients who had A1C readings above 9% at baseline and received 8 mg of oral insulin once daily experienced a 1.26% placebo adjusted reduction in A1C by week 12.
“We are looking forward to discussing with the FDA our planned Phase 3 trial,” concludes Kidron. “We are additionally very pleased with the progress of our Chinese partners, HTIT, who will also be initiating Phase 3 trials for our oral insulin and might even become the first to reach commercialization.”