MannKind Announces Data Presentation At 14th International Conference On Advanced Technologies & Treatments For Diabetes (ATTD 2021) To Be Held Virtually June 2-5

Rhea-AI Summary

MannKind Corporation (Nasdaq: MNKD) announced a poster presentation at the ATTD 2021 conference showcasing a post hoc analysis from the STAT study. This analysis revealed that Afrezza (Technosphere Insulin) significantly reduced nocturnal hypoglycemia in adults with type 1 diabetes, showing a 62% reduction in Level 1 and a 78% reduction in Level 2 hypoglycemia compared to insulin aspart. The study included 60 patients over four weeks and highlighted Afrezza's ultra-rapid action as a potential benefit. Larger studies are needed to validate these results.

Positive

• Afrezza reduced nocturnal hypoglycemia by 62% for Level 1 and 78% for Level 2 compared to insulin aspart.
• The STAT study's results may enhance understanding and application of Afrezza in treating type 1 diabetes.

Negative

• The study was small, involving only 60 patients, suggesting limited generalizability of results.
• Results need confirmation through larger studies, indicating ongoing uncertainty regarding Afrezza's efficacy.

WESTLAKE VILLAGE, Calif., June 3, 2021 /PRNewswire/ -- MannKind Corporation (Nasdaq: MNKD), which focuses on the development of innovative medicines for patients with endocrine and orphan lung diseases, announced today that it will present a poster [Abstract #654 / Topic AS09 – New Insulin Delivery Systems: Inhaled, Transdermal, Implanted Devices] at the 14^th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2021) to be held virtually, June 2-5. The poster presents a post hoc analysis from the STAT study that demonstrates how Afrezza (Technosphere Insulin or TI) reduced nocturnal hypoglycemia compared to insulin aspart in adult patients with type 1 diabetes (T1D).

"When the STAT study was completed, it advanced our understanding of potential benefits of Afrezza for those living with Type 1 diabetes overall," said Dr. Kevin Kaiserman, Vice President, Medical Affairs and Safety of MannKind. "With this post hoc statistical analysis, we divided the CGM data into day and night and showed that using Technosphere Insulin versus aspart reduced Level 1 nocturnal hypoglycemia by 62% and Level 2 by 78%."

The ultra-rapid appearance and clearance of TI – which more closely mimics physiologic insulin compared with subcutaneous insulin aspart – may contribute to these findings, although larger studies are needed to confirm this hypothesis, Kaiserman explained.

The STAT study was a four-week, investigator-led, collaborative, open-label pilot study that included 60 patients with T1D on multiple daily injections of aspart who were randomized to either the control cohort using aspart (n=34) or the TI cohort (n=26).  Level 1 (<70 mg/dL) and Level 2 (<54 mg/dL) hypoglycemia measures were obtained from continuous glucose monitors (CGM). For purposes of the study, nighttime was defined as 12 am to 6 am.

The poster is authored by Janet K. Snell-Bergeon, PhD; Halis K. Akturk, MD; Anne Peters, MD; Kevin Kaiserman, MD and Satish K. Garg – representing a collaboration between the Barbara Davis Center for Diabetes (University of Colorado-Aurora), Keck School of Medicine of USC, and MannKind.

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.comhttp://www.mannkindcorp.com/ to learn more.

Forward-looking Statements 
This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes", "anticipates", "plans", "expects", "intends", "will", "goal", "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind'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 various risks and uncertainties, which include, without limitation, the risk that continued testing of Afrezza may not yield successful results or results that are consistent with earlier testing, and other risks detailed in MannKind's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2020 and subsequent periodic reports on Form 10-Q and current reports on 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 press release.

AFREZZA and TECHNOSPHERE are registered trademarks of MannKind Corporation.

 

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SOURCE MannKind Corporation

FAQ

What were the key findings of MannKind's STAT study presented at ATTD 2021?

The STAT study showed that Afrezza reduced nocturnal hypoglycemia by 62% for Level 1 and 78% for Level 2 compared to insulin aspart.

When was the ATTD 2021 conference where MannKind presented?

The ATTD 2021 conference was held virtually from June 2-5, 2021.

What is the significance of Afrezza in treating type 1 diabetes according to MannKind's findings?

Afrezza's ultra-rapid action may provide a significant benefit in reducing nocturnal hypoglycemia for patients with type 1 diabetes.

What is the sample size of MannKind's STAT study?

The STAT study involved a total of 60 patients with type 1 diabetes.

What does the future hold for Afrezza based on the PR from MannKind?

MannKind suggests that larger studies are necessary to confirm the findings of the STAT study.