MannKind Announces New Clinical Data From Inhale-3 Study to be Presented by Dr. Irl B. Hirsch at ATTD on March 8
05 Marzo 2024 - 5:05AM
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 new clinical data from
the INHALE-3 study first meal challenge will be presented at the
upcoming 17th International Conference on Advanced Technologies and
Treatments for Diabetes (ATTD) in Florence on March 6-9. INHALE-3
is a Phase 4 U.S. clinical trial evaluating inhaled insulin (plus
basal) vs. standard of care.
Dr. Irl B. Hirsch, Professor of Medicine and Diabetes Treatment
and Teaching Chair at the University of Washington and the INHALE-3
Study Protocol Chair, will provide an oral presentation focused on
findings from a standardized meal challenge, including:
- Post-prandial glucose with inhaled insulin vs. subcutaneous
rapid-acting analogue (RAA)
- Glucose outcomes including AUC and time to peak during the
first two hours and beyond
- Frequency of post-meal hypoglycemia in both groups
“We are looking forward to the first slice of INHALE-3 data
being presented here that builds upon findings from our pilot ABC
study shared at last year’s ATTD Conference,” said Dr. Kevin
Kaiserman, Senior Vice President, Clinical Development and Medical
Affairs for MannKind Corporation. “With ABC and this trial, we used
a higher initial conversion dose for inhaled insulin than in our
current label. In the ABC study, this conversion dose produced
significantly lowered post-prandial glucose levels that peaked 30
minutes sooner than standard of care. At ATTD, we are presenting
INHALE-3’s meal challenge with a much larger comparator group
across treatment regimens.”
Dr. Hirsch will deliver his oral presentation at 11:15 a.m. EST
(5:15 p.m. CET) on Friday, March 8, 2024. Further data will be
provided post-conference.
INHALE-3 is a 17-week randomized controlled trial with a 13-week
extension. The study randomly assigned participants over 18 years
of age with T1D who are using MDI, an AID system, or a pump without
automation to either continue their standard of care or adopt an
insulin regimen of a daily basal injection plus Afrezza at
mealtimes. Both arms utilized 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, 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.
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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