MannKind Announces Completion of Enrollment in U.S. Phase 4 Inhale-3 Clinical Trial in Patients Living With Type 1 Diabetes
November 06 2023 - 6:15AM
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 has fully enrolled
patients in INHALE-3, a Phase 4 clinical trial evaluating inhaled
insulin (combined with basal insulin) versus usual care in adults
living with type 1 diabetes.
“We are excited to see the high level of engagement by INHALE-3
investigators, study staff, and subjects across 19 sites
nationwide,” said Dr. Kevin Kaiserman, Senior Vice President,
Clinical Development and Medical Affairs for MannKind Corporation.
“This was a rapid enrollment process, and we are looking forward to
sharing results in 2024.”
INHALE-3 is a 17-week randomized controlled trial with a 13-week
extension. The study will randomly assign participants over 18
years of age with T1D who are using Multiple Daily Injections
(MDI), an automated insulin delivery (AID) system, or a pump
without automation to either continue their usual care or adopt an
insulin regimen of a daily basal injection plus Afrezza at
mealtimes. Both arms will utilize continuous glucose monitoring to
assess mealtime control and A1c levels. More information on the
study is available at: ClinicalTrials.gov(NCT05904743).
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 StatementsThis press release
contains forward-looking statements about the planned release of
results from an ongoing clinical study 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 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 after the date of this press release.
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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