The first study 030 compared the pulmonary safety of meal-time inhalation of Afresa versus usual care in over 2000 patients with type 1 and type 2 diabetes. The study met its primary endpoint: after two years of treatment, no adverse effects were observed on patients’ lungs in the Afresa-treated group.
The second study 102 compared the efficacy of meal-time Afresa in combination with long-acting basal insulin versus twice daily injections of pre-mixed insulin. Study 102 met its primary endpoint, showing comparable improvements in HbA1c levels over 52 weeks between the two treatment groups.
The company expects to disclose more details of the top-line data from these studies in patients with type 1 and type 2 diabetes by mid-December 2008.
Peter Richardson, chief scientific officer of MannKind, said: We are very pleased to announce the positive outcome of these, the last of our three pivotal Phase III studies. We look forward to presenting more complete data, including analyses of secondary endpoints, as soon as they are available, which are expected before the end of 2008.
Afresa promises to be an important additional option for the treatment of patients with diabetes. Our next step is to finalize a new drug application for Afresa, which we expect to submit to the FDA in early 2009.