VALENCIA, Calif., Dec. 18 MannKind Corporation(Nasdaq: MNKD) today released preliminary top-line results from two pivotalPhase 3 clinical studies of AFRESA(TM), the company's ultra rapid actinginsulin product (Studies 102 and 030). The protocols for these studies werereviewed and prospectively approved by the FDA under its special protocolassessment (SPA) procedure. As previously announced, both studies achievedtheir primary endpoints.
Study 102 - comparable decreases in A1C levels
Study 102 compared the efficacy of meal-time AFRESA in combination with along-acting basal insulin versus twice daily injections of pre-mixed insulin(a mixture of rapid-acting insulin and intermediate-acting insulin) inpatients with type 2 diabetes. A total of 323 patients were randomized to theAFRESA group and 331 patients were randomized to the pre-mix group.
Over the 52-week period of this study, A1C levels decreased comparably inthe two treatment groups, 0.59 in the AFRESA group and 0.71 in the pre-mixgroup. The 95% confidence interval (0.29%) of the between-group differencedid not exceed the predetermined threshold of 0.40%, thereby establishing non-inferiority between AFRESA and pre-mixed insulin.
Other study highlights:
-- A comparable percentage of patients reached A1C target levels in eachtreatment group.
-- There was a significantly greater decrease in fasting blood glucoselevels in the AFRESA group compared to pre-mixed insulin.
-- Patients in the AFRESA group gained significantly less weight than didpatients in the pre-mix group.
-- Severe hypoglycemic events were significantly less common in the AFRESAgroup than in the pre-mix group
-- There were no between-group differences in pulmonary function measures,including FEV1 (forced expiratory volume in one second), FVC (forced vitalcapacity), DLCo (carbon monoxide diffusing capacity) and TLC (total lungcapacity).
-- These preliminary results are subject to further statistical analysis.
Study 030 - no adverse effect on lung function
Study 030 compared the pulmonary safety of meal-time inhalation of AFRESAversus usual care (the comparator group). A total of 938 patients with type 1and type 2 diabetes were randomized to the AFRESA group; 951 patients wererandomized to the comparator group. An additional 164 subjects withoutdiabetes were enrolled into a third arm in order to assess the effect ofdiabetes on pulmonary function.
The primary endpoint of Study 030 was pre-specified with the FDA as abetween-group difference (AFRESA-treated vs. comparator group) of less than 50mL per year in the decline from baseline measures of FEV1 over the entirestudy period. After two years of treatment, the difference between mean FEV1values for the two treatment groups was 37 mL (95% CI: 14-60 mL) -- wellwithin the 100 mL pre-defined limit. Non-inferior results were also observedin secondary measures of lung function, including FVC, TLC and DLCo.
Other study highlights:
-- On average, patients in the AFRESA group gained less weight than didpatients in the comparator group or subjects without diabetes.
-- Comparable decreases were observed in A1C levels between the AFRESA-treated group and the comparator group
-- Severe hypoglycemic events were significantly less common in the AFRESAgroup compared to the comparator group.
These preliminary results are subject to further statistical analysis.
Dr. Peter Richardson, MannKind's Chief Scientific Officer, commented, "Weare continuing to analyze the results of our pivotal Phase 3 clinical studies,and plan to share more data at upcoming investor presentations and theAmerican Diabetes Association scientific meeting in June. In addition, weanticipate shortly the completion of the bioequivalency study that comparesthe clinical version of our inhaler to the more rugged and less costlycommercial version. With this gating item behind us, we are now focusing onreadying our new drug application for AFRESA for submission to the FDA earlyin the new year."
AFRESA is an ultra rapid acting insulin product that has completed Phase 3trials. The pharmacokinetic profile of AFRESA sets it apart from all otherinsulin products. The large surface area of the lung provides unique access tothe circulatory system. The pH-sensitive AFRESA particles immediately dissolveupon contact with the lung surface, releasing insulin monomers that rapidlyenter the bloodstream. It achieves peak insulin levels within 12-14 minutesof administration, effectively mimicking the release of meal-time insulinobserved in healthy individuals, but which is absent from patients withdiabetes.
About MannKind Corporation
MannKind Corporation (Nasdaq: MNKD) focuses on the discovery, developmentand commercialization of therapeutic products for patients with diseases suchas diabetes and cancer. Its pipeline includes AFRESA, which has completedPhase 3 clinical trials, and MKC253, which is currently in phase 1 clinicaltrials. Both of these investigational products are being evaluated for theirsafety and efficacy in the treatment of diabetes. MannKind maintains a websiteat http://www.mannkindcorp.com to which MannKind regularly posts copies of itspress release as well as additional information about MannKind. Interestedpersons can subscribe on the MannKind website to email alerts that are sentautomatically when MannKind issues press releases, files its reports with theSEC or posts certain other information to the website.
This press release contains forward-looking statements, includingstatements related to the promise for AFRESA, next steps in the Company'sclinical trial program, plans and timing for the submission of a new drugapplication and expectations regarding potential position and use of AFRESA inthe market. Words such as "believes", "anticipates", "plans", "expects","intend", "will", "goal", "potential" and similar expressions are intended toidentify forward-looking statements. These forward-looking statements arebased upon MannKind's current expectations and involve risks anduncertainties. Actual results and the timing of events could differ materiallyfrom those anticipated in such forward-looking statements as a result of theserisks and uncertainties, which include, without limitation, risks related tothe progress, timing and results of clinical trials, difficulties or delays inseeking or obtaining regulatory approval, MannKind's ability to enter into anycollaborations or strategic partnerships, MannKind's ability to raiseadditional financing and other risks detailed in MannKind's filings with theSecurities and Exchange Commission, including the Annual Report on Form 10-Kfor the year ended December 31, 2007 and periodic reports on Form 10-Q andForm 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. Allforward-looking statements are qualified in their entirety by this cautionarystatement, and MannKind undertakes no obligation to revise or update anyforward-looking statements to reflect events or circumstances after the dateof this news release.
SOURCE MannKind Corporation