MannKind Corporation Announces Positive Results From A Phase 2b Dose-Ranging Study Of Technosphere(R) Insulin In Patients With Type 2
VALENCIA, Calif., Jan. 17 /PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD - News) today announced results from a phase 2b dose-ranging study of Technosphere® Insulin, an inhaled insulin formulation delivered via the Company's proprietary inhaler to patients with diabetes mellitus. Technosphere® Insulin was observed to improve glycemic control in a dose-dependent manner as measured by decreases in HbA1c levels (a measure of the average amount of blood sugar over the preceding three to four months) and in glucose excursions following a meal. Importantly, there was no indication of a negative effect on pulmonary function and no weight gain at any dose of Technosphere® Insulin over 12 weeks of treatment.
"The reduction in post-prandial glucose excursions is becoming of much greater interest due to the finding that these excursions may be involved in the pathogenesis of diabetic vascular disease. This study clearly showed that Technosphere® Insulin produced the desired effect on glycemic control," commented Dr. Irl Hirsch, an internationally-recognized expert on diabetes. Dr. Hirsch is a Professor of Medicine and the Medical Director of the Diabetes Care Center at the University of Washington Medical Center. He is also the 2004 recipient of the Outstanding Physician Clinician in Diabetes Care Award by the American Diabetes Association.
The phase 2b dose-ranging study was designed to evaluate the effect of different mealtime doses of Technosphere® Insulin added to a single fixed daily injection of basal insulin glargine (Lantus®) in patients with type 2 diabetes. In total, 227 patients were studied. Patients were followed on their existing therapy for four weeks, then transferred to insulin glargine, and subsequently randomized to receive, in a double blind fashion, either inhaled placebo (consisting of Technosphere® particles only) or Technosphere® Insulin at dosages of 14, 28, 42 and 56 units. Patients who received Technosphere® Insulin were force-titrated to their pre-assigned dose and remained on that dose for the duration of the study. HbA1c levels and post-prandial glucose excursions were assessed at the initial visit, at the start of randomized treatment and at study completion. Comparisons were made between the groups receiving Technosphere® Insulin and the group receiving placebo. Pulmonary safety was assessed by serial measurements of lung function, including forced expiratory volume (FEV1) and carbon monoxide lung diffusing capacity (DLco).
The study demonstrated that the addition of Technosphere® Insulin to insulin glargine produced a statistically significant, dose-dependent reduction in HbA1c levels and in post-prandial glucose excursions. In patients treated for eight weeks at 56 units (n=45), the mean reduction in percent HbA1c levels was 0.79 below that observed in the placebo group (p=0.0002). Also, at 56 units, the maximal post-prandial glucose excursion was reduced to only 34 mg/dl, a 63% reduction compared to the placebo group (p<0.0001). No reduction of pulmonary function was observed over 12 weeks, as measured by FEV1 and DLco. Additionally, no change in weight was observed at any dose in the group receiving Technosphere® Insulin, and no severe hypoglycemic episodes were seen throughout the study.
Dr. Peter Richardson, Chief Scientific Officer of MannKind, commented, "This study met its primary objective and further supports the Technosphere® Insulin dosing regimen currently being evaluated in our phase 3 trials. The results are consistent with the Company's previous studies on Technosphere® Insulin that demonstrated improved glycemic control in patients with diabetes, reduced post-prandial glucose excursions, no deterioration in pulmonary lung function, and no weight gain associated with Technosphere® Insulin at any of the dosage levels tested. Collectively, these data demonstrate a potential advantage of Technosphere® Insulin over standard insulin therapies."
About MannKind Corporation
MannKind Corporation (Nasdaq: MNKD - News) focuses on the discovery, development and commercialization of therapeutic products for diseases such as diabetes and cancer. Its lead investigational product candidate, the Technosphere® Insulin System, is currently in phase 3 clinical trials in the U.S. and Europe to study its safety and efficacy in the treatment of diabetes. For more information on MannKind Corporation and its technology, visit www.mannkindcorp.com.
This press release contains forward-looking statements, including statements related to MannKind's clinical trials and product candidates that involve risks and uncertainties. Words such as "believes", "anticipates", "plans", "expects", "intend", "will", "goal", "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the Company's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the progress, timing and results of clinical trials, the risk that future safety and efficacy studies may not confirm our past clinical results, risks related to intellectual property matters, difficulties or delays in seeking or obtaining regulatory approval, risks related to manufacturing the Company's lead product candidate, risks related to competition from other pharmaceutical or biotechnology companies, risks related to the Company's ability to enter into any collaborations or strategic partnerships or obtain additional financing to support the Company's operations, risks related to the Company's ability to meet milestones and other risks detailed in MannKind's filings with the SEC, including the Annual Report on Form 10-K for the year ended December 31, 2004 and periodic reports on Form 10-Q and Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this news release.
Lantus® is marketed by sanofi-aventis.
Source: MannKind Corporation