MannKind Corp. (MNKD) recently announced encouraging results from the much awaited phase III Affinity studies on its lead candidate Afrezza. Afrezza is being developed for the treatment of type I or type II diabetes. Afrezza met primary end points in both the studies.
Results from the Study 171 (n= 518) revealed that non-inferior decreases in A1c levels were observed in Afrezza treated patients compared to the insulin aspart group. This was the primary objective of the study. Afrezza was found to be well tolerated during the study.
MannKind also issued a new press release to correct the previously announced results from the Study 171 on Afrezza in patients suffering from type I diabetes. Results in the new press release revealed that the event rate of severe hypoglycemia was lower in patients under the Afrezza group compared to those under the insulin aspart group.
Meanwhile, MannKind’s share price, which had shot up 7.1% initially on the positive data, spiralled 12.5% following the corrigendum.
Results from the other phase III study on Afrezza (type II diabetes), Study 175 (n=353), showed that the primary objective of superior reductions in A1c levels from baseline was observed in the Afrezza group compared to the comparator oral-therapy group. Moreover, more patients under the Afrezza group reached specified A1c target levels compared to those in the comparator oral-therapy group. The candidate was generally well tolerated in this study as well.
MannKind now plans to file the amended new drug application to the U.S. Food and Drug Administration for the candidate in early fourth quarter of 2013. The company will now enter into a formal partnering process as the Affinity results have been declared. The company will assess the opportunities of the candidate along with multiple partners.
The positive results from the company’s lead candidate are encouraging. We expect investor focus to remain on Afrezza going forward. However, we remain concerned about the company’s over dependence on Afrezza. Any setback related to the diabetes candidate will be catastrophic for MannKind.
MannKind, a biopharma stock, presently carries a Zacks Rank #3 (Hold). Other biopharma stocks, such as Actelion Ltd. (ALIOF), Alexion Pharmaceuticals, Inc. (ALXN) and Amarin Corporation (AMRN) are comparatively well placed. While Actelion carries a Zacks Rank #1 (Strong Buy), Alexion and Amarin carry a Zacks Rank #2 (Buy).
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