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, today announced six-month results from its
Phase 3 INHALE-1 study of Afrezza (insulin human) Inhalation Powder
in children and adolescents (aged 4-17 years of age). MannKind
expects to submit a request for a supplemental new drug application
(sNDA) meeting with the U.S. Food and Drug Administration (FDA) in
1H 2025 to discuss the data and filing timeline.
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. Kevin
Kaiserman, Senior Vice President, Therapeutic Area Head, Endocrine
Diseases for MannKind Corporation.
“It was exciting to partner with MannKind and help lead this
study to potentially expand the use of inhaled insulin, which is
currently used successfully by many adults with diabetes, to a
population that hasn’t had a treatment option other than injectable
insulin in the history of their care,” said Dr. Roy W. Beck,
founder of the Jaeb Center for Health Research who provided
oversight for INHALE-1. “The six-month results are clinically
meaningful and show Afrezza as a potential future treatment option
for a growing pediatric population living with type 1 and type 2
diabetes.”
Conference CallMannKind will host a live audio
webcast beginning at 8:30 a.m. Eastern Time on Monday, December 16,
2024, to share results and discuss the company’s diabetes program
progression. Participating in the conference call from MannKind
will be Chief Executive Officer Michael Castagna, PharmD and
Dr. Kaiserman. The webcast will be accessible via a link on
MannKind’s website at
https://investors.mannkindcorp.com/events-and-presentations. A
replay will also be available in the same location within 24 hours
following the call and be accessible for approximately 90 days.
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 on
Afrezza.com/safety.
About MannKindMannKind Corporation (Nasdaq:
MNKD) focuses on the development and commercialization of
innovative inhaled 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, 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 visit mannkindcorp.com to learn more, and follow us on
LinkedIn, Facebook, X or Instagram.
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 Securities and Exchange Commission, including
under the “Risk Factors” heading of its Annual Report on Form 10-K
for the year ended December 31, 2023, 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 MANNKIND are registered trademarks of MannKind
Corporation.
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/12f4dac8-7936-41b3-a2ad-7eef85fe3712
For MannKind:
Media Relations
Christie Iacangelo, (818) 292-3500
Email: media@mnkd.com
Investor Relations
Ana Kapor, (415) 377.2882
Email: ir@mnkd.com
MannKind (NASDAQ:MNKD)
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