MannKind Still Bullish on Inhalable Insulin

Hearsay is that Al Mann, CEO of MannKind Corp., is one of those people who’s either brilliant, crazy, or a combination thereof. Probably the latter. And I guess you’d have to be to keep pushing ahead on developing a powdered inhalable insulin product in the wake of Pfizer’s colossal flop Exubera.

I interviewed Al Mann last November (when their product Afrezza was still spelled with an ‘s’).  I thought his claims about this new mealtime (bolus-dose) inhalable insulin sounded pretty outlandish then, so I wouldn’t have been surprised if the clinical trials tanked. But they did not. The company made several announcements at this year’s ADA Conference on very positive research results showing its safety and even superior performance over traditional insulin use (improved control and less hypoglycemia).

I spoke with Dr. Peter Richardson, Chief Scientific Officer of MannKind, at ADA to learn a little more about how it’s possible for patients to do so well on a medication that seems like it couldn’t possibly be absorbed in the precise amounts required.  Backed by the research data and some fancy charts and graphs, Richardson presented compelling details.  Not being a scientist myself, I have no way of vetting this information, but it sure sounds amazing.  According to the company:

- Afrezza allows a person’s own remaining insulin to “kick in” and contribute to BG control (so the patient “recovers some insulin sensitivity”)

- there is less variability in absorption than with injections (especially important for type 1s, where absorption from shots varies by temperature, site scarring, etc.)

- Afrezza peaks in 10 minutes, which is far speedier than any injectable insulin

I also queried Richardson on the “logistics” of daily use.  It seems the mechanics of their dosing have changed a bit since last fall. I was now told that single cartridges of Afrezza will contain either 4 or 8 units of insulin, and will be color-coded so patients don’t get mixed up.  The cartridges will come in sealed foil packs that patients can throw in a purse or bag along with the little “Dreamboat” inhaler for easy portability.  The inhaler itself is meant to disposed of and replaced every two weeks. This is due to powder buildup, which could clog the mechanism.  Afrezza needs only to be kept at room temperature, not refrigerated.

MannKind has already received a response letter from the FDA and is working on further demonstrating the “clinical utility” of Afrezza, which Richardson says is a somewhat nebulous term. Notably, they now have permission to start pediatric studies (!)  Their first step will be to confirm that kids can easily understand and use the device. That should be a no-brainer, because any kid who can do their own shots can master this little inhaler.

I bumped into my own endo near the MannKind booth after the interview, and we conferred for a moment. We ended up shrugging at each other and saying, “If it really works the way they say, with those kind of results — wow, this could be big!  Who knows?”

In other words, I’m certainly rooting for MannKind to accomplish the breakthrough of bringing a valid inhalable insulin to market, but I’m also not holding my breath.