MannKind Announces Six-Month Results From Phase 3 INHALE-1 Pediatric Diabetes Trial Utilizing Inhaled Insulin (Afrezza®)
MNKD 12.16.2024
- Company plans to meet with FDA regarding potential sNDA submission in 1H 2025
- Call planned today at
8:30 a.m. (ET) to discuss company’s diabetes program progression
The INHALE-1 study is a 26-week, open-label clinical trial that randomized 230 subjects to one of two groups: Afrezza or multiple daily injections (MDI) of rapid acting insulin analog (RAA) in combination with basal insulin. The primary endpoint was a non-inferior change in HbA1c levels after 26 weeks. A 26-week extension phase in which all remaining MDI patients switched to Afrezza is still ongoing.
Results were as follows:
*mITT analysis excludes one outlier from the primary ITT endpoint who failed to adhere to the study protocol
An analysis of the full intent-to-treat population (ITT) found that the between-group difference in mean HbA1c change over 26 weeks exceeded the prespecified non-inferiority margin of 0.4% (0.435%), largely driven by the variability of a single patient who did not adhere to the study protocol. A modified ITT (mITT) analysis, which excluded this subject, did not exceed the predetermined threshold of 0.4% (0.370%), thereby establishing the non-inferiority of Afrezza to MDI, which was the primary endpoint of the study.
Over 26 weeks of treatment, no difference in lung function parameters were seen between the treatment groups. The Afrezza-treated patients had a mean FEV1 of 2.901 liters (99.6% of predicted) at baseline and 2.934 liters (96.6% of predicted) at 26 weeks. MDI-treated patients had corresponding mean FEV1 values of 2.948 liters (102.3% of predicted) and 2.957 liters (98% of predicted), respectively. Additional safety findings, including for hypoglycemia, did not show any significant concerns or differences between the treatment groups.
“The overall efficacy and safety outcomes seen in the first 26 weeks are encouraging. This represents a monumental step in our more than 25-year history of pioneering the development of inhaled insulin and working to bring this new treatment option to children and adolescents over the past seven years,” said Dr.
“It was exciting to partner with
Conference Call
About AfrezzaAfrezza (insulin human) Inhalation Powder is a rapid-acting inhaled human insulin indicated to improve glycemic control in adults with diabetes mellitus.
Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis or in patients that smoke or have recently stopped smoking.
Important Safety Information
WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE
- Acute bronchospasm has been observed in Afrezza-treated patients with asthma and COPD
- Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD
- Before initiating Afrezza, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients.
Most common adverse reactions are hypoglycemia, cough, and throat pain or irritation.
Please see additional Important Safety Information, Full Prescribing Information, including BOXED WARNING, available onAfrezza.com/safety.
About
We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. 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, depending on the target indication.
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 visitmannkindcorp.comto learn more, and follow us onLinkedIn,Facebook,XorInstagram.
Forward-Looking StatementsThis press release contains forward-looking statements about a planned meeting with the FDA, a potential sNDA submission and the potential expanded use of Afrezza that involves 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 issues that develop in the review by the FDA may subject us to unanticipated delays or prevent us from obtaining the expanded indication as well as other risks detailed in MannKind’s filings with the
AFREZZA and
A photo accompanying this announcement is available athttps://www.globenewswire.com/NewsRoom/AttachmentNg/12f4dac8-7936-41b3-a2ad-7eef85fe3712
ForMannKind :Media RelationsChristie Iacangelo , (818) 292-3500Email: media@mnkd.com
Investor RelationsAna Kapor , (818) 661-5000Email: ir@mnkd.com
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Source: MannKind