Those with diabetes know the everyday struggle to maintain blood sugar levels at that sweet spot between too high and too low. In order to test their blood glucose levels, diabetic patients have to prick their fingers often and take medication. Many also inject insulin daily to control their blood sugar. Hoping to make patients' lives a litle easier, researchers have felt that an oral insulin pill may do the deed.
Luckily, an Israeli company, Oramed Pharmaceuticals, has just received approval from the U.S. Food and Drug Administration (FDA) to ship their experimental drug, ORMD-0801, around the U.S. The drug is a formulation of insulin that can be taken in pill form before a meal to control blood sugar levels. The Investigational New Drug (IND) Application approval is required before clinical trials can progress and allows for the drug to be transported and distributed across state lines.
Oramed is pursuing the drug as a treatment for type 1 diabetes, also known as juvenile diabetes, and type 2 diabetes. Children with diabetes typically have to have an insulin pump with them at all times and a port installed in their abdomen so that they can have a constant insulin supply. The availability of this pill would help children to better adhere to their medication schedule.
The company had submitted its IND application on April 12 and announced today that the FDA has approved it. The company will now begin a 147-patient multi-center phase II clinical trial for type 2 diabetes in the U.S., and a large phase II trial is forthcoming."We are very pleased to have the FDA clearance to proceed," stated Nadav Kidron, CEO of Oramed. "The upcoming trial is a major milestone for Oramed and we look forward to continuing to progress ORMD-0801's clinical development in the US."
The aim for the type 2 diabetes trials is to slow the degenerative nature of the disease by taking some of the stress off of the pancreas in insulin production. The company indicated that the drug would be used at the early stages of type 2 diabetes initially.
Oramed has previously shown positive results of clinical trials using the drug for type 1 diabetes in a poster at the Global Technology Community Diabetes Summit 2013, which was held in Boston from April 29-30. The results showed that the drug helped stabilize glucose levels in patients who had uncontrolled blood sugar levels. The company also published the results in PLOSOne.
Insulin therapy for diabetes was first begun at the turn of the 20th century, where insulin was purified from fetal calf pancreas, and the first patient was saved using insulin injections in 1922. The first biotechnology drug was human insulin, created by Genentech (the first biotechnology company, now owned by Roche) and Eli Lilly, using the bacteria E. coli as factories for the protein. The drug hit the market in 1982, with the name Humulin, and is now the only major type of insulin used by diabetics globally. This new formulation of insulin could be one of the first major changes in more than 30 years for drugs and for diabetic patients.