VALENCIA, Calif., Nov. 5 /PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD) today announced results from a Phase 1a clinical evaluation of MKC253, a formulation of GLP-1 (glucagon-like peptide) on Technosphere particles that is delivered using the Company's proprietary inhaler. The study was designed as an open-label, dose escalation, controlled safety and tolerability trial, involving 26 healthy, adult, male subjects. Each subject was assigned to one of five dose levels of MKC253 inhalation powder: 0.05 mg, 0.45 mg, 0.75 mg, 1.05 mg or 1.5 mg.
The primary objective of the trial was to evaluate the tolerability of ascending doses of the investigational product as determined by the incidence and severity of reported adverse events. Secondary endpoints included pharmacokinetic parameters of plasma GLP-1 and pharmacodynamic parameters of plasma insulin and glucose.
GLP-1 plasma concentrations peaked very quickly, with a mean Tmax occurring less than 3 minutes after inhalation. In the group that received 1.5 mg of MKC253, the mean Cmax of total GLP-1 was 507 pmol/L, with active GLP-1 reaching a Cmax of 310 pmol/L. At all dose levels, MKC253 was well tolerated. Even in subjects that achieved plasma GLP-1 concentrations in excess of 100 pmol/L, the nausea and vomiting characteristically associated with such levels was not observed.
In these healthy subjects, GLP-1-induced insulin release occurred
within 6 minutes of inhalation of MKC253. The insulin response was
dose-dependent. The release of insulin from the pancreas was confirmed by
corresponding significant increases in the levels of C-peptide. In subjects
that received 1.5 mg of MKC253, blood glucose concentrations were observed
|SOURCE MannKind Corporation|
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