I had the most absurdly frustrating phone briefing yesterday with a company developing a very promising new technology for delivering insulin in an oral gel cap: Oramed Pharmaceuticals based in Jerusalem, Israel. Oddly, I was contacted by their PR/Investor Relations firm with the express purpose of “getting the word out to the public,” but trying to pry any of the key details out of their execs felt a bit like talking to the Israeli Secret Service. Nada.
I’m only telling you about all this because Oramed’s product really does look promising, as opposed to other attempts at oral insulin that haven’t quite panned out (think Exubera, and at least two other insulin tablets that appear to be stalled in development, Intesulin and Emisphere).
* “Up until now, the idea of insulin pills or tablets was inconceivable due to the fact that insulin, which is a protein, breaks down in the digestive system.” However, Oramed’s patented technology overcomes this barrier by “mimicking the physiological entry of insulin into the bloodstream by bypassing digestion in the stomach. It is absorbed through the intestines, and is filtered and regulated through the liver into the bloodstream.”
* The company has struck an advantageous deal with Swiss Caps AG, one of the largest softgel capsule manufacturers, in which this manufacturer requested equity in exchange for their services. (A strong endorsement for Oramed’s future success — who wants equity in a company that won’t hit it big?)
* They’ve completed successful Phase 1A human trials in Israel, albeit it with healthy, non-diabetic subjects. But the effect on insulin, glucose, and C-peptide levels were “quite significant” without any negative side effects. According to Dr. Miriam Kidron, pharmacist and biochemist behind the product, it’s very difficult to show these type of results in people without diabetes, so Oramed supporters are very encouraged.
* They hope to complete Phase 1 studies in the US by mid-next year. Meanwhile, they’ll begin Phase 2 trials with diabetic patients in Israel in the next few months. These studies will not count directly toward the FDA approval process (which will go significantly slower due to stringent regulations), but will rather expedite development and launch of the product in countries like South Africa and South America within about year and a half if all goes well.
* Making their way through the stringent FDA approval process will probably put off market launch in the US until about 2010. (Hey, if it really works, I can wait)
* As of now, the tablet is used “more similar to a bolus, but could also be applied like a basal insulin, as a once-a-day dosage.” Wait, what does this mean? This is where things got confidential. Actual dosage and usage details are still top secret, apparently. Hmmph.
btw, Oramed is also developing future flu pill to replace the flu shot, helping to rid medicine of more needles.
But Dr. Kidron is patient-savvy enough to note that most PWDs who use needles aren’t all that desperate to get rid of them. “The advantage of oral insulin is not to avoid injections, but to mimic the natural way insulin is absorbed. With filtering through the liver, everything you eat will be absorbed by delivery,” she says.
What exactly does that mean? I’m afraid they’re not comfortable talking about it publicly just now. Guess we’ll just have to stick to our usual modus operandi: wait and see…