What is the biggest problem with treating Type 1 diabetes? The experts all say it's that the insulins we have to inject simply aren't fast enough; they don't really mimic the effect of natural pancreas delivery because they take too long to kick in.
Several companies are rushing to solve this problem with the obvious: super-fast-acting insulin analogs, such as the relatively new Glulisine (aka Apidra), and BioDel's ViaJect, currently being submitted for FDA review.
But achieving perfect timing, so that your insulin levels are high enough during meals, and not too high several hours later, remains elusive (lyrically stated).
A company called Halozyme Therapuetics based in San Diego, CA, may have a better answer: they're developing an enzyme that can be injected along with your insulin that aids and speeds insulin absorption. The stuff is called Insulin PH20, and it's being tested with Type 1 diabetics in Phase 2 studies right now.
On a recent investors' earnings call, a company executive explained:
"We designed this Phase 2 study to compare glycemic control of a standardized liquid meal challenge and insulin pharmacokinetics or PK after administration of each of four dosage regimens. Humulin R with and without PH20 and Humalog with and without PH20. The combination doses of insulin plus enzyme are co-mixed and administered to the patients as a single injection. This crossover design single blind, open label, liquid meal steady collects data on at least 20 patients who will complete the trial."
To me, this sounds exciting and scary at the same time; is there not enormous potential for mistakes, causing severe hypoglycemia?
According to the company, they're looking at measure called "AUC," or area under the curve -- the goal being to keep patients at steady BG levels for the first 60 minutes after the injection of the drug (and during meal consumption).
They argue that the faster absorption and onset will not only "more closely resemble mealtime insulin release in a healthy person" but will also be followed by a "faster offset" so that patients won't go low. The tangible benefits for us, they say, would be "less hypoglycemia, better glycemic control, and possibly less weight gain."
Hmmm... again, a very provocative innovation that may or may not go mainstream and actually change our lives any time soon.
The good news for me is that Halozyme will be presenting more data in early June at the American Diabetes Association annual meeting in New Orleans -- and I will be there to blog it live! I'll let you know what I hear.
Meanwhile, I'd love to hear from you: in case anyone knows anything else juicy and newsworthy about Insulin PH20 right now?