MannKind Corporation has announced that preliminary results from two Phase 3 clinical studies of Afrezza inhaled insulin met their primary endpoints. In a study in patients with Type 1 diabetes comparing Afrezza to insulin aspart, Afrezza was shown to be non-inferior in A1c level decreases and showed significant reductions in fasting blood glucose and significantly less hypoglycemia. In a study in patients with Type 2 diabetes, Afrezza compared to oral therapy alone demonstrated significant reductions in A1c levels.
The first study (Study 171) also compared Afrezza delivered by the second generation Dreamboat inhaler and the first generation MedTone inhaler and found no difference in pulmonary function with the two devices. According to MannKind Chairman and CEO Alfred Mann, “the use of Afrezza was associated with a clinically insignificant decrease in lung function that appeared at the onset of therapy, did not progress during therapy and resolved fully upon cessation of therapy.”
Mann also commented, “We are pleased that both Phase 3 studies met their primary efficacy endpoints and that Study 171 also achieved its other main objective of demonstrating comparability between the Gen2 and MedTone inhalers. The positive results of Study 171 and Study 175 will form the basis of an amendment to our new drug application for Afrezza, which we expect to submit to the Food and Drug Administration early in the fourth quarter of this year.”
Read the MannKind press release on both studies.
Read the MannKind press release on Study 171.
Read the MannKind press release on Study 175.
