MannKind reports positive late-stage study results for diabetes therapy Afrezza

MannKind stock gained as much as 27 percent Wednesday after the company said two Phase III trials of its experimental inhaled insulin therapy Afrezza met their main goals in patients with type 1 and type 2 diabetes. CEO Alfred Mann said the preliminary results "will form the basis of an amendment to our new drug application for Afrezza, which we expect to submit to the FDA early in the fourth quarter of this year."

In study 171, which involved 518 patients with type 1 diabetes on basal/bolus insulin therapy, patients were randomised to receive Novo Nordisk's NovoLog (insulin aspart), or Afrezza administered with either its next-generation Gen2 inhaler or the MedTone inhaler. After 24 weeks, results showed that Afrezza demonstrated non-inferiority to NovoLog, with A1c levels lowered by 0.21 percent in the Afrezza-Gen2 arm, versus 0.40 percent in the NovoLog arm. MannKind reported that mean fasting blood glucose levels declined significantly in the Afrezza-Gen2 arm, having decreased 25.3 mg/dL by the end of the treatment period, compared with an increase of 10.2 mg/dL for the NovoLog group. Moreover, significantly fewer hypoglycaemia events occurred in the Afrezza-Gen2 arm compared with those treated with NovoLog. MannKind said patients in the Afrezza-Gen2 group also lost an average of 0.39 kg, while patients in the NovoLog arm gained 0.93 kg.

Study 175 consisted of 353 patients with type 2 diabetes whose disease was inadequately controlled by either metformin alone or in combination with a second or third oral drug. Patients were randomised to receive Afrezza or placebo administered using the Gen2 inhaler, in addition to their oral medication for 24 weeks. The study found that Afrezza when combined with oral therapy resulted in superior A1c reductions, compared with oral therapy alone. Specifically, mean A1c levels decreased by 0.82 percent in Afrezza-treated patients, versus 0.42 percent in the placebo arm. Additionally, 37.7 percent of patients in the Afrezza group achieved A1c levels of less than 7 percent, compared to 19 percent in the placebo group. The incidence of postprandial glucose excursions was also lower in the experimental group compared to the placebo group, the company said.

MLV & Co analyst Graig Suvannavejh anticipates Afrezza will garner regulatory approval, but questioned whether the company could successfully commercialise the product. "I think it really will depend on who the exact partner is, as this product is going to require a lot of education, a lot of heavy lifting," he said, adding that potential partners include Novo Nordisk, Sanofi, Bristol-Myers Squibb, Merck & Co. , Eli Lilly and Johnson & Johnson. The analyst estimates that Afrezza could generate US and European sales of about $3 billion by 2025.

The FDA declined to approve Afrezza in January 2011 and requested additional studies of the drug conducted using the Gen2 inhaler instead of the MedTone inhaler. The agency previously issued a complete response letter to MannKind regarding Afrezza in March 2010, citing a need for additional clinical data to support the clinical utility of the therapy.

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