• Inhaled Technosphere^® Insulin (TI) lowered peak glucose levels 30 minutes faster than injectable rapid-acting insulin delivered through an AID insulin pump and significantly lowered post-prandial glucose (PPG) from 45-120 minutes after a controlled meal challenge test
  
• MannKind is planning a larger switch study in type 1 diabetes (T1D) to evaluate inhaled insulin with once-daily basal insulin in patients that switch from rapid-acting insulin given through multiple daily injections or any insulin pump delivery system

WESTLAKE VILLAGE, Calif., Feb. 22, 2023 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that it will present an oral presentation describing meal challenge results at the 16^th International Conference on Advanced Technologies & Treatment for Diabetes (ATTD) in Berlin February 22-25.

Dr. Kevin Kaiserman, Vice President, Medical Affairs, Endocrine Business Unit for MannKind, will report meal challenge results from the Afrezza with Basal Combination proof-of-concept study during an oral presentation delivered on Feb 25.

The data showed that subjects utilizing inhaled Technosphere Insulin lowered peak glucose levels 30 minutes faster (200 mg/dl at 60 minutes) than subjects utilizing a rapid-acting analogue (RAA) with an Automated Insulin Delivery (AID) system (264 mg/dl at 90 minutes). Subjects utilizing TI also experienced a significantly lower mean PPG from 45 to 120 minutes post-meal.

“We believe inhaled insulin is an important option for those living with type 1 diabetes to reduce their PPG in the first 120 minutes,” said Dr. Kaiserman. “The study revealed a faster and lower peak in glucose that may assist patients in achieving improved glycemic control.”

“We are steadfast in our commitment to addressing the serious unmet need to improve mealtime control for those living with diabetes,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “Based on the data collected from this pilot study we intend to move forward with a larger study this year to evaluate how we can reduce the diabetes burden as well as improve a patient’s ability to control their sugars in the first 120 minutes after they eat.”

Twenty-six adults with type 1 diabetes using AID systems completed the pilot study. The inhaled TI group (21 participants) utilized an inhaled insulin dose to cover a standardized meal whereas the AID control group (five participants) used AID-administered RAA to cover the standardized meal. Each participant consumed 37g of a nutritional shake (1 can of Boost^®). Glucose was measured by self-monitored blood glucose (SMBG) at 15–30-minute intervals over two hours. The inhaled TI dosing used in this trial simplified the conversion from RAA that is contained in the current prescribing information. This dosing regimen was reported in a recently published study showing this new dose conversion provides better PPG control and does not give rise to any new safety concerns such as severe hypoglycemia.

Additional analysis from the ABC trial is expected to be presented at future conferences.

About MannKind

MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of innovative therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases.

We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, pulmonary arterial hypertension (PAH) and nontuberculous mycobacterial (NTM) lung disease. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation.

With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life.

Please visit mannkindcorp.com to learn more, and follow us on LinkedIn, Facebook, Twitter or Instagram.

Forward-Looking Statements

This press release contains forward-looking statements about the implications of clinical data and plans for future study 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 an investigational drug product may not yield successful results or results that are consistent with earlier testing, as well as 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, 2021 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.

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