Afrezza: Phase III data

Preliminary data from the double-blind, placebo-controlled, international Phase III AFFINITY 2 trial (Study 175) in 353 Type II diabetics showed that Afrezza administered via MannKind's next-generation Dreamboat inhaler added to patients' oral therapy met the primary endpoint of superiority to placebo plus oral therapy in reducing mean HbA1c levels from baseline to 24 weeks (0.82% vs. 0.42%, p<0.0001). Furthermore, a greater proportion of patients in the Afrezza arm achieved HbA1c target levels of <7% (37.7% vs. 19%, p=0.0005) and <6.5% (15.9% vs. 4.2%, p=0.0021) at week 24 vs. placebo.

On secondary endpoints at week 24, Afrezza did not significantly reduce mean fasting blood glucose levels from baseline vs. placebo (11.2 mg/dL vs. 3.8 mg/dL reduction, p=0.1698). Patients receiving Afrezza gained an average of 0.49 kg from baseline vs. an average loss of 1.13 kg in patients receiving placebo (p<0.0001). Furthermore, Afrezza significantly increased mild and moderate hypoglycemia (67.2% vs. 30.1%, p<0.0001) and non-significantly increased severe hypoglycemia (5.1% vs. 1.7%, p=0.0943) from baseline vs. placebo. Afrezza was well tolerated and the most common adverse event was cough. The trial enrolled Type II diabetics who are inadequately controlled on metformin with or without a second or third oral medication. ...