MannKind completes patient recruitment in two Afrezza Phase 3 studies

Afrezza is an investigational, ultra rapid-acting mealtime insulin therapy, administered using MannKind’s to-be-marketed next-generation inhaler.

MannKind chairman and chief executive officer Alfred Mann said the completion of the patient recruitment is the initial element 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," Mann added.

The study 171, first of the studies, is an open-label study in patients with type 1 diabetes which compares the safety profile of the two AFREZZA treatment groups.

The primary outcome measure of the study 171 is a 12-week observation period on stable doses of the mealtime insulin to assess HbA1c levels.

The study 175, the other study, is designed to assess the Afrezza using the next-generation inhaler in patients with type 2 diabetes whose disease is inadequately controlled on metformin with or without a second or third oral medication.

It will also have a titration period, followed by a 12-week evaluation period to assess HbA1c levels.