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

Rhea-AI Summary

MannKind Corporation (Nasdaq: MNKD) presented two posters at the American Diabetes Association's virtual 81^st Scientific Sessions from June 25-29, focusing on its inhaled insulin, Afrezza^®. Poster 923-P details a Phase 2 clinical study demonstrating the pharmacokinetics and safety of Afrezza in pediatric patients with type 1 diabetes, showing no severe hypoglycemic events. Poster 722-P presents findings from a Levin study indicating that Afrezza helps reduce hyperglycemia in patients with uncontrolled type 2 diabetes, improving daytime time-in-range by 83.5%. MannKind is set to initiate a Phase 3 study in fall 2021.

Positive

• Phase 2 study shows that Afrezza is safe and effective for pediatric type 1 diabetes patients.
• No severe hypoglycemic events were reported during the pediatric study.
• Study 722-P indicates Afrezza improves glycemic control in uncontrolled type 2 diabetes, reducing hyperglycemia by 76.4%.
• Strong rationale to initiate a Phase 3 safety and efficacy study in pediatric patients expected in fall 2021.

Negative

• None.

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 81^st 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-P
An 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-P
Poster 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 (<54 mg/dl) (p=0.0938).

"Daytime time-in-range continues to be the most challenging aspect of living with diabetes," said Dr. Philip Levin. "The data demonstrated that adding mealtime insulin helped decrease time spent in hyperglycemia and improved glycemic control for patients with T2D."

About Afrezza^®
Available by prescription, Afrezza^® (insulin human) Inhalation Powder is an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within minutes of administration. Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients may use a combination of existing cartridge strengths. For more information about Afrezza, please visit afrezza.com.

About MannKind Corporation
MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza^® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra-rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. Afrezza is also available by prescription in Brazil, where it is commercialized by the Company's partner, Biomm SA. MannKind was established in 1991, and is headquartered in Westlake Village, Calif., with a manufacturing and R&D facility based in Danbury, Conn. The Company also employs field sales and medical representatives across the U.S. Please visit mannkindcorp.com to learn more.

AFREZZA and TECHNOSPHERE are registered trademarks of MannKind Corporation.

 

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SOURCE MannKind Corporation

FAQ

What did MannKind present at the American Diabetes Association's Scientific Sessions?

MannKind presented two posters focusing on its inhaled insulin, Afrezza, detailing studies on its safety and efficacy in pediatric type 1 diabetes and uncontrolled type 2 diabetes.

What were the results of the Phase 2 study on Afrezza for children?

The Phase 2 study showed that Afrezza had a rapid peak in insulin concentrations with no severe hypoglycemic events in pediatric patients aged 8 to 17 with type 1 diabetes.

How does Afrezza affect patients with type 2 diabetes according to Poster 722-P?

Poster 722-P reported that Afrezza reduced daytime hyperglycemia by 76.4% and improved time-in-range by 83.5% for patients with uncontrolled type 2 diabetes.

When will the Phase 3 study for Afrezza in pediatric patients begin?

MannKind plans to initiate the Phase 3 safety and efficacy study for Afrezza in pediatric patients in the fall of 2021.