MannKind Corporation (NASDAQ:MNKD) opened strong Monday morning, after the company presented Afrezza clinical data from three different studies at the American Diabetes Association's 79th Scientific Sessions.
The company, based in Westlake Village, Calif., said it will present a poster with initial information from its ongoing study of Safety and Pharmacokinetics of Technosphere Insulin (Afrezza) in Pediatric Patients on Monday. The news release issued Sunday declared this study would be the first step in preparation for a phase 3 safety and efficacy study.
In pediatric patients, the rapid rise in insulin concentrations corresponded with early postprandial glucose control within the first hour post-dose. The profile is similar to that previously observed in adults.
Consistent with its safety profile in adults, Afrezza was generally well-tolerated in pediatric patients; most treatment emergent adverse events were of mild severity, and no severe hypoglycemia was observed.
These data will help guide the finalization of the protocol for a phase 3 safety and efficacy study.
Said MannKind Chief Medical Officer David Kendall "We are excited to share the progress of the ongoing pediatric study program.
"As is well known, type 1 diabetes is often diagnosed in children and adolescents, and these individuals will continue to require insulin therapy throughout their lives. Evaluating as quickly as possible the potential use of Afrezza in children and adolescents as an option for mealtime insulin therapy is a top priority for MannKind."
MannKind shares acquired nine cents, or 7.6%, to $1.28
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