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MannKind Reports Positive Data From A Phase 3 Clinical Study Of AFREZZA In Patients With Type 1 Diabetes

Second graph under Other Results subhead, second sentence should read: The event rate of severe hypoglycemia was also lower in the AFREZZA-Gen2 group (8.05 events per 100 subject-months) than in the insulin aspart group (14.45 events per 100 subject-months); however, this difference was not statistically significant (p=0.1022) (sted The event rate of severe hypoglycemia was also lower in the AFREZZA-Gen2 group (8.05 events per subject-month) than in the insulin aspart group (14.45 events per subject-month); however, this difference was not statistically significant (p=0.1022)).

The corrected release reads:

MANNKIND REPORTS POSITIVE DATA FROM A PHASE 3 CLINICAL STUDY OF AFREZZA IN PATIENTS WITH TYPE 1 DIABETES

MannKind Corporation (Nasdaq: MNKD) today announced positive preliminary results from Study 171, a Phase 3 clinical study of AFREZZA ® (insulin human [rDNA origin]) Inhalation Powder, an investigational, ultra rapid-acting mealtime insulin therapy, administered using MannKind’s next-generation (Gen2) inhaler (also known as the Dreamboat™ inhaler), in patients with type 1 diabetes.

Highlights

AFREZZA-Gen2, compared to insulin aspart, showed:

  • Non-inferior decreases in A1c levels;
  • Significantly less hypoglycemia;
  • Significant decreases in fasting blood glucose levels; and
  • Significant weight advantage.

In addition, the changes in pulmonary function observed in the AFREZZA-Gen2 group were no different than those observed in an AFREZZA treatment group that utilized MannKind’s first-generation (MedTone) inhaler. This finding will facilitate bridging the Gen2 inhaler to the pulmonary safety data that was collected in earlier clinical studies using the MedTone inhaler.

“We are pleased that Study 171 met its primary endpoint of non-inferiority, by demonstrating that AFREZZA produces A1c reductions comparable to insulin aspart,” stated Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. “Importantly, this study also established a bridge between the Gen2 inhaler and the large body of pulmonary safety data that was previously collected for AFREZZA using the MedTone inhaler. Consistent with previous studies of AFREZZA, including a two-year safety study involving 2,035 subjects, 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. Based on the results of this study, we believe that AFREZZA can be used to achieve glycemic control that is comparable to the current standard of care while at the same time offering potential advantages in terms of lower fasting blood glucose levels, weight neutrality and a lower overall risk of hypoglycemia.”

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