MannKind Corporation (MNKD) recently completed a phase III study (Study 175: n=353) 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 II diabetes. The study assessed Afrezza using the next-generation inhaler in patients whose disease is insufficiently controlled by metformin. Patients enrolled in the study were randomized to either Afrezza or placebo.
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.
Last month MannKind completed its first phase III study (Study 171) on Afrezza in patients suffering from type I diabetes. The 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.
During its first quarter 2013 conference call, MannKind stated that it plans to resubmit the New Drug Application to the FDA 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 Public Limited Company (JAZZ), Santarus, Inc. (SNTS) and Cubist Pharmaceuticals Inc. (CBST), are comparatively well placed. While Jazz Pharma and Santarus carry a Zacks Rank #1 (Strong Buy), Cubist Pharma carries a Zacks Rank #2 (Buy).
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