MannKind's Two Phase 3 Studies Of Afrezza Positive, Meet Primary End Points

(RTTNews) - MannKind Corp. (MNKD) Wednesday reported positive preliminary results from Study 175 and Study 171, two Phase 3 clinical studies of Afrezza Inhalation Powder, an investigational, ultra rapid-acting mealtime insulin therapy administered using MannKind's next-generation inhaler, also known as the Dreamboat inhaler. The studies also met primary endpoints.

MannKind said study 175 recorded superior reductions in A1c levels in type 2 patients and reduced glucose excursions after food intake. In study 171 in type 1 patients, significantly less hypoglycemia and reduction in fasting blood sugar noticed.

Study 171 was an open-label study involving 518 patients with type 1 diabetes on basal/bolus insulin therapy who were studied at sites in the United States, Russia, Ukraine and Brazil. Study 175 was a double-blind, placebo-controlled study involving 353 patients with type 2 diabetes whose disease was inadequately controlled on metformin with or without a second or third oral medication.