Drug maker MannKind Corp. (MNKD) Tuesday announced results from an open-label, single dose, three-way crossover study indicating that its mealtime insulin therapy Afresa provided rapid suppression of endogenous glucose production, compared with subcutaneous insulin lispro and inhaled Exubera in adult patients with type 2 diabetes. The results were presented at the 45th annual meeting of the European Association for the Study of Diabetes.
Findings were based on endogenous glucose production suppression in 18 insulin-treated subjects with type 2 diabetes mellitus and normal pulmonary function administered 45 U Afresa administered by inhalation, 12 IU subcutaneous insulin lispro or 4 mg inhaled Exubera. The main study end-point was time to Endogenous Glucose Production suppression.
Endogenous glucose arises from liver due to the breakdown of stored starches, while exogenous glucose arises from ingested food. Suppression of Endogenous Glucose Production is one of insulin's primary metabolic effects, and failure of this action is a major contributor to the high post-meal glucose concentrations associated with type 2 diabetes mellitus. It also significantly increases the risk of fasting hyperglycemia in individuals with type 2 diabetes. About 23.6 million in the US or 8% of the US population is indicated to have Diabetes.
Afresa, a mealtime insulin therapy, is a drug-device combination product, consisting of Afresa Inhalation Powder pre-metered into single use dose cartridges and the light, discreet and easy to use Afresa Inhaler. The phase 2/3 clinical program included over 4,500 adult patients.
The U.S. Food and Drug Administration is currently reviewing a New Drug Application requesting approval to market Afresa Inhalation Powder and the Afresa Inhaler for use in adult patients with type 1 and type 2 diabetes mellitus for the treatment of hyperglycemia. Afresa is conveniently administered by oral inhalation.
"Many people do not appreciate that most of the excess postprandial glucose increase in individuals with diabetes is due to inadequate suppression of endogenous glucose production by the liver," said Jay Skyler, Professor, Division of Endocrinology, Diabetes, & Metabolism, Associate Director, Diabetes Research Institute, University of Miami Miller School of Medicine.
MNKD is currently trading at $10.10,up $0.30 or 3.06%, on a volume of 2.26 million shares.
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