Phase 3 Afresa pulmonary function safety data presented

Phase 3 pulmonary function safety data for Afresa (insulin human [rDNA origin] inhalation powder, from MannKind Corp.) was presented at the American Diabetes Association's (ADA) 69th Scientific Session. Results from the prospective, multicenter, two-year study showed no difference in mean change in forced expiratory volume in one second (FEV(1)) between those treated with Afresa and those treated with standard insulin therapy. Findings were based on pulmonary function tests (PFTs) in patients with type 1 and type 2 diabetes receiving Afresa or usual antidiabetic treatment, along with nondiabetic patients. The main study endpoint was the change from baseline in pre-bronchodilator FEV(1) at two years. Secondary endpoints included change from baseline in other PFT parameters (forced vital capacity, total lung capacity, and carbon monoxide diffusion test). Consistent with the normal course of aging, PFTs declined in all groups. Based on the predefined endpoint there was no difference in mean change in FEV(1) from baseline to 24 months between Afresa and usual antidiabetic treatment.

Afresa is a novel, ultra rapid acting mealtime insulin therapy, administered by oral inhalation, with an action profile that mimics meal-related early insulin release. It is being studied for use in adult patients with type 1 and type 2 diabetes for the treatment of hyperglycemia.

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