This can be big news, because the only GLP-1 now available, Byetta, requires injections twice a day. Still, it can be a long way from announcement to availability in your nearest drugstore.
The announcement is “a proof of concept study in healthy subjects” by seven researchers, including people associated with Emisphere Technology in Tarrytown, New York.
This company developed what it calls “the eligen technology,” that enables large molecules, like GLP-1, to cross membranes in the gut that they otherwise can’t. That’s why until now GLP-1 has to be taken by injection.
The abstract 03-LB, “Pharmacokinetics and Pharmacodynamic Effects of Oral Glp-1 and Pyy3-36,” isn’t online yet, so I can’t link it. But it concluded that the study “showed for the first time that satiety peptides such as GLP-1 and PYY3-36 can be delivered orally in humans.”
We don’t yet have any drugs based on the PYY 3-36 hormone, although Amylin Pharmaceutics says that it has a combination with pramlintide (Symlin) in Phase 1 trials for obesity.
But it could plays a critical role in decreasing our appetites, making us aware of feeling full. It has the opposite role of the hormone ghrelin, which increases our appetite.
All of these hormones, including insulin, might also be taken as a spray nasally. That’s what the first inhaled insulin, Exubera, is. But it’s not perfect, with potential lung problems and lesser bioavailability, as I wrote here when the Food and Drug Administration approved it in January.
Amylin Pharmaceuticals has reported that it has a nasal version of Byetta (exenatide) in Phase 1 trials. I’ve heard rumors that Amylin may also be working on an oral version of Byetta. So as soon as I read about the oral GLP-1 in development I called Alice Bahner Izzo, Amylin’s executive director for investor relations.
“Amylin hasn’t announced any work on an oral version of Byetta,” she told me.
That does not mean that the company is not working on it. It may be, since not everything the pharmaceutical companies are doing is public knowledge. But it certainly does look now like the biggest limitation with the hottest diabetes drug may be approaching resolution.