MannKind Corporation recently completed its phase III clinical study (Study 171: n=518) on its diabetes candidate Afrezza. MannKind completed all follow-up visits for the enrolled patients in the study. The company expects to publish data from the study later this summer.
The open-label phase III study evaluated Afrezza inhalation powder in patients suffering from type I diabetes. The patients were 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. Following the titration of the mealtime insulin, HbA1c levels were assessed for an observation period of 12 weeks on the stable doses of the mealtime insulin.
We remind investors that in Jan 2011, MannKind had received a second complete response letter (CRL) from the US Food and Drug Administration (FDA) for Afrezza. The FDA had asked the company to conduct two phase III trials with the next-generation inhaler.
The second study (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. This study is also expected to be completed soon.
During its first quarter 2013 conference call, MannKind stated that it plans to resubmit the New Drug Application for Afrezza in late September or early October this year. MannKind intends to get Afrezza approved for treating adults suffering from type 1 or type 2 diabetes. We expect investor focus to remain on Afrezza going forward.
MannKind currently carries a Zacks Rank #3 (Hold). Other biopharma stocks, such as Jazz Pharmaceuticals (JAZZ - Analyst Report) , Santarus Inc. and Cubist Pharmaceuticals Inc. are comparatively well placed. While Jazz Pharma and Santarus carry a Zacks Rank #1 (Strong Buy), Cubist Pharma carries a Zacks Rank #2 (Buy).