MannKind begins two pivotal phase 3 studies of inhaled Technosphere Insulin

By Lisa Kerner

Erie, Pa., March 6 - MannKind Corp. said it has started patient enrollment in two pivotal 12-month phase 3 clinical trials of Technosphere Insulin (TI) in patients with type 1 and type 2 diabetes.

The goal of the studies is to evaluate the efficacy of TI by assessing changes both in HbA1c levels as well as in blood glucose levels after a standardized meal, according to a company news release.

The MannKind inhaled insulin delivery system consists of a proprietary dry powder Technosphere formulation of insulin inhaled using the company's proprietary MedTone inhaler.

Study 009, the first of the new trials, will compare TI to subcutaneous injections of a rapid-acting insulin analog in 500 patients with type 1 diabetes. Patients in both arms of this study will also receive a basal insulin regimen.

The second trial, Study 102, will compare TI plus basal insulin to subcutaneous injections of premixed insulin (including a rapid-acting insulin analog) in 500 type 2 diabetes patients. This study was the subject of a special protocol assessment by the Food and Drug Administration in the fall of 2005, the release stated.

One additional trial, Study 103, is slated to begin this summer.

"We are confident that these two new studies will further confirm the safety and efficacy that we have seen to date," chief scientific officer Peter Richardson said in the release.

"Our prior studies have shown improved glycemic control in a dose-dependent manner as measured by decreases in HbA1c levels, and by significant reductions in glucose excursions following a meal."

In the coming months, MannKind said it intends to share results from Study 101 - a three-month phase 3 study in patients with type 1 diabetes - and Study 014 - a six-month phase 3 study in patients with type 2 diabetes.

MannKind will discuss the new pivotal studies during its presentation at the Cowen & Co. 26th Annual Health Care Conference. A link of the conference presentation will be available for a short time on the company's web site (www.mankindcorp.com).

MannKind, based in Valencia, Calif., discovers, develops and commercializes therapeutic products for diseases such as diabetes and cancer.

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