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MannKind Announces Positive Results from a Phase 1a Study of a GLP-1 Formulation
Date:11/5/2007

for a period of approximately 20 minutes after inhalation. All subjects were fasted prior to the administration of MKC253.

A greater proportion of the GLP-1 inhaled as MKC253 remained intact during the period following administration than has been described in the literature following subcutaneous or intravenous injection of GLP-1. In this study, doses of 1.05 mg and 1.5 mg of MKC253 produced a ratio of active-to-total GLP- 1 of approximately 67% whereas ratios of 20 - 33% have been reported following intravenous administration of GLP-1.

"Our hypothesis at present is that delivery of active GLP-1 to the arterial circulation via the lung avoids much of the degradation by dipeptidyl peptidase-4 that occurs prior to the compound reaching the primary site of endocrine action. Thus, we may be able to achieve a different response profile with pulmonary MCK253 than that seen with subcutaneous or intravenous administration of GLP-1. Moreover, the pulsatile administration of MKC253 achieved with our proprietary Technosphere delivery technology appears to avoid the dose-limiting vomiting characteristically associated with GLP-1 and replaces a physiological response lost in patients with diabetes that cannot be replicated by other forms of GLP-1," said Dr. Peter Richardson, Corporate Vice President and Chief Scientific Officer. "As well, with pulsatile delivery, we may potentially avoid unusual adverse effects such as the acute pancreatitis that has been described with presently marketed GLP analogues."

"We believe that MKC253 represents a novel approach to the use of GLP-1 as a prandial therapy for diabetes either alone, or in combination with prandial insulin. In addition, if we are able to demonstrate the same weight reduction or satiety effects seen with long-acting analogues of native GLP, MKC253 may have therapeutic potential in obesity. At present, this indication for GLP-1 is currently limited by the need to administer peptide hormones by injection. T
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