MannKind Announces Enrollment Goal Completion of INHALE-1 Pediatric Diabetes Trial Utilizing Afrezza®
February 15 2024 - 6:05AM
MannKind Corporation (Nasdaq: MNKD), a company
focused on the development and commercialization of inhaled
therapeutic products for patients with endocrine and orphan lung
diseases, announced today that it has fully enrolled 305 patients
living with type 1 or type 2 diabetes in its INHALE-1 study
assessing efficacy and safety of inhaled insulin in the pediatric
population.
As reported by pediatric study investigator Lori Laffel, MD,
MPH, “There remains a need for innovative insulin preparations to
help manage glucose levels at mealtimes in children and adolescents
living with diabetes.” Dr. Laffel is Chief of the Pediatric,
Adolescent and Young Adult Section at Joslin Diabetes Center and
Professor of Pediatrics at Harvard Medical School. Dr. Laffel goes
on to note that “It is especially important that young people have
as many treatment options as their adult counterparts with
diabetes, and this trial has the potential to expand the treatment
choices for children and adolescents living with diabetes.”
INHALE-1 is a 26-week open-label, randomized clinical trial with
a 26-week extension. The primary endpoint is change in HbA1c level
after 26 weeks. Secondary endpoints include change in fasting
plasma glucose after 26 weeks and rate of hypoglycemic events. The
multi-center study evaluated Afrezza in combination with basal
insulin vs. multiple daily injections (MDI) of insulin in children
and adolescents aged 4-17 who are living with type 1 or type 2
diabetes.
“We are excited to reach this milestone in exploring the
potential of Afrezza for a younger generation living with
diabetes,” said Dr. Kevin Kaiserman, Senior Vice President,
Clinical Development and Medical Affairs for MannKind Corporation.
“We expect to complete a primary endpoint analysis in the fourth
quarter.”
More information on the study details is available at:
https://www.clinicaltrials.gov/study/NCT04974528
About MannKindMannKind 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 StatementsStatements in this
press release that are not statements of historical fact are
forward-looking statements that involve risks and uncertainties.
These statements include, without limitation, statements regarding
the completion of randomization and the read-out of an ongoing
clinical study as well as a potential regulatory submission. 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 we may not achieve our projected development goals in
the timeframes we expect, 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, 2022, 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.
AFREZZA and MANNKIND are registered trademarks of MannKind
Corporation.
For MannKind:
Christie Iacangelo, Corporate Communications
(818) 292-3500
Email: media@mannkindcorp.com
Rose Alinaya, Investor Relations
(818) 661-5000
Email: ir@mannkindcorp.com
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