MannKind Presents Two Posters At American Diabetes Association's Virtual 81st Scientific Sessions, June 25-29

- Poster 923-P: Phase 2 clinical study results revealed similar tolerability and time-action profile of Technosphere® Insulin in pediatric subjects as in published data for adults; provides rationale for conducting a Phase 3 study

- Poster 722-P: Data shared that Technosphere Insulin improved daytime time-in-range in people with type 2 diabetes

WESTLAKE VILLAGE, Calif., June 25, 2021 /PRNewswire/ -- MannKind Corporation (Nasdaq: MNKD), which focuses on the development of innovative medicines for patients with endocrine and orphan lung diseases, will present two posters at the American Diabetes Association's virtual 81st Scientific Sessions, June 25-29.  The submissions include 923-P in Pediatrics-Type 1 Diabetes, and 722-P in Clinical Therapeutics/New Technology-Insulins.  MannKind is also hosting a booth in the virtual Exhibit Hall at the Scientific Sessions.

Poster 923-PAn insulin regimen that closely mimics physiologic insulin for pediatric patients with type 1 diabetes (T1D) remains a critical goal.  Poster 923-P reports on a Phase 2 clinical study to characterize the pharmacokinetics (PK) and safety of prandial Afrezza® (Technosphere® Insulin or TI) in 30 children aged 8 to 17 years with T1D.  Afrezza – an ultra rapid-acting dry-powder prandial insulin – is currently indicated to improve glycemic control in adults with T1D or type 2 (T2D) diabetes.

"The final results from the phase 2 pediatric study revealed that serum insulin concentrations peaked rapidly within 10-15 minutes of inhaled administration of TI, similar to the results observed previously in adults.  In addition, there were no severe hypoglycemic events or clinically relevant declines in pulmonary function, and no new or unexpected signals with TI," said Dr. Kevin Kaiserman, Vice President, Medical Affairs and Safety of MannKind and the presenting author of the study. "The pharmacokinetics and safety results provide us the rationale to move forward with conducting a phase 3 safety and efficacy study in pediatric patients with diabetes, which we expect to initiate in the fall."

PK measurements were obtained in 30 patients with T1D (median age of 12.7 years). Patients met criteria of using insulin for at least one year, and were on a stable regimen of basal-bolus insulin therapy for six weeks or greater. Insulin PK and blood glucose were assessed following single doses of TI.

Poster 722-PPoster 722-P presents a retrospective analysis of data from the Levin study, an investigator-initiated trial sponsored by MannKind, to determine the effect of prandial inhaled insulin on daytime glucose levels in people with uncontrolled type 2 diabetes.  For purposes of the study, daytime was defined as 6:00 am to midnight.

• Twenty T2D patients who had never been on mealtime insulin before were started on TI and rapidly titrated during the first week and followed for 12 weeks.
• On average, patients showed an 83.5% increase in daytime time-in-range (70-180 mg/dL).
• The study concluded that TI reduced patients' daytime time spent in hyperglycemia (>250 mg/dl) by 76.4% (p=0.0002) and without a significant increase in daytime time spent in hypoglycemia (