MannKind Corporation says that it has completed recruitment of patients for two Phase 3 studies of Afrezza inhaled insulin. One of the studies will assess HbA1c levels in Type 1 diabetes patients using either injected rapid-acting insulin, Afrezza delivered with the MedTone inhaler, or Afrezza delivered by MannKind’s next generation inhaler. The second study involves Type 2 diabetes patients with inadequate control of the disease using metformin alone and will compare Afrezza delivered by the next-gen inhaler to a placebo inhalation powder.
MannKind Chairman and CEO Alfred Mann commented, “Completing patient recruitment is the initial element, and often the lengthiest, in the conduct of large scale Phase 3 clinical trials. Both studies are on track to be completed in the second quarter of 2013 and we expect to report top-line results next summer. Our objective is to resubmit the NDA for Afrezza in the third quarter of next year.”
Read the MannKind press release.
