MannKind gains on Phase III Afrezza data

Shares of MannKind Corp. (NASDAQ:MNKD) closed up $0.73 (11%) to $7.59 on Wednesday after the company said Afrezza met the primary endpoint in a pair of Phase III trials evaluating the dry powder formulation of insulin administered with an inhaler to treat Type I and Type II diabetes. Next quarter, MannKind plans to resubmit an NDA for Afrezza with an amendment including data from the trials, which were requested by FDA in a January 2011 complete response letter (see BioCentury Extra, Jan. 20, 2011).

In the Phase III Study 171 trial in 518 Type I diabetics, Afrezza administered via MannKind's next-generation Dreamboat inhaler met the primary endpoint of non-inferiority to subcutaneous rapid-acting insulin aspart in reducing HbA1c from baseline to week 24 (0.21% vs. 0.40%, 95% CI: 0.02%, 0.36%). The 95% CI of the between-group difference was below 0.40%, the pre-determined threshold for non-inferiority. Additionally, Afrezza administered via Dreamboat met the trial's main safety endpoint of non-inferiority in the mean change in forced expiratory volume in 1 second (FEV1) from baseline to week 24 vs. patients who received Afrezza administered via MannKind's first-generation MedTone inhaler. ...