MannKind Corporation recently announced the completion of the patient recruitment process for its phase III clinical studies (study 171 and study 175) of Afrezza. Afrezza is an ultra rapid-acting mealtime insulin therapy being developed for the treatment of type I and type II diabetes.
The first study (171) is evaluating the candidate in patients suffering from type I diabetes. In this study, patients are randomized to one of three arms: a control arm, in which patients utilize injected rapid-acting insulin at mealtimes, or one of two Afrezza arms, with patients either on MedTone or the next-generation inhalers.
The second study (175) is evaluating Afrezza in patients suffering from type II diabetes. This study will assess Afrezza using the next-generation inhaler in patients who are inadequately controlled on metformin, with or without a second or third oral medication. Further, patients will be randomized to either Afrezza or placebo.
MannKind believes that it can complete both trials in the second quarter of 2013 and submit a new drug application by the third quarter of 2013.
Notably, in January 2011, MannKind had received a second complete response letter (CRL) from the US Food and Drug Administration (FDA) for Afrezza. The FDA asked the company to conduct these two phase III trials with the next-generation inhaler.
Following the receipt of the second CRL, MannKind trimmed its workforce by approximately 41% and cancelled its insulin supply deal with N.V. Organon, a subsidiary of Merck & Co. Inc. (MRK - Analyst Report) .
Currently, we have a Neutral recommendation on MannKind, which carries a Zacks #3 Rank (short-term Hold rating). MannKind is primarily dependent on the successful development of Afrezza and we expect investor focus to remain on the same.