MannKind (MNKD -1.68%) announced breathtaking news this week -- literally. The biotech completed patient recruitment for two phase 3 clinical trials for its insulin inhalant Afrezza. The "breathtaking" studies should begin soon and be completed in the second quarter of 2013.
Studying the studies
While both phase 3 studies involve Afrezza, they are quite different in nature. The first will include at least 471 patients with type 1 diabetes. Three arms will be used in the study -- a control arm, an arm using Afrezza with MannKind's older MedTone inhaler, and a third arm using Afrezza with the company's newer inhaler.
The second study will include at least 328 patients with type 2 diabetes. The patients will go through an initial run-in period using metformin, an oral antidiabetic medication. The study will then compare patients using Afrezza versus a placebo inhalation powder.
MannKind likely feels a sense of deja vu in conducting these phase 3 studies. The company went down this road before a few years ago with Afrezza, the drug formerly known as Afresa. I guess marketing studies found that "zz" tops "s" in product naming.
All went well until the company decided to switch inhalers. While the move resulted in a multi-year delay, it probably was the right thing to do.
Pfizer (PFE 1.00%) failed in its marketing of an insulin inhalant from Nektar Therapeutics (NKTR 9.68%). Lilly (LLY 0.69%) and Novo Nordisk (NVO 2.08%) couldn't successfully launch their products either.MannKind saw improving its inhaler as the best opportunity to avoid a similar fate.
Looking ahead
As MannKind CEO Alfred Mann pointed out in his public statements about the studies, completing patient recruitment often is the lengthiest part of conducting phase 3 clinical trials. Reaching this milestone is significant.
However, MannKind still has a long way to go to ultimately bring Afrezza to market. The company must raise some more cash to make it happen. And it needs a partner in a major way.
Afrezza holds great promise for many diabetics. My guess is that it will ultimately achieve success. However, until MannKind finds a well-heeled partner, I doubt the stock will be very successful. In the meantime, I'm not holding my breath.
