INHALE-3 Study’s Initial Meal Challenge Results Comparing Afrezza® Head-To-Head With Multiple Daily Injections (MDI) and Insulin Pumps
March 11 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 initial meal challenge data from
INHALE-3 that was presented by Dr. Irl B. Hirsch at the 17th
International Conference on Advanced Technologies and Treatments
for Diabetes (ATTD) in Florence on March 8th. INHALE-3 is a Phase 4
U.S. clinical trial evaluating inhaled insulin (plus basal) vs.
standard of care.
The statistically significant findings included:
- Subjects utilizing inhaled insulin experienced significantly
reduced post-meal hyperglycemia, compared with those who used
subcutaneous rapid-acting analogues (RAA) delivered by MDI or pumps
- Area under the curve (AUC; 180 mg/dL) was reduced by 20%
- Inhaled insulin subjects demonstrated significantly lower
glucose excursions from baseline
- Mean glucose excursions were reduced by 22%
- In the inhaled insulin group, mean glucose levels peaked 15
minutes sooner than in the standard of care group despite inhaled
insulin being given at start of the meal vs. RAA being administered
5-15 minutes prior to the meal
“Clinician have been seeking options for people living with
diabetes in hopes of identifying treatments that provide improved
mealtime control,” said Dr. Hirsch, Professor of Medicine and
Diabetes Treatment and Teaching Chair at the University of
Washington and the INHALE-3 Study Protocol Chair. “It is exciting
to share data from this study’s standardized meal challenge,
demonstrating inhaled insulin can help address this unmet
need.”
The 17-week endpoint results from INHALE-3 will be presented
Saturday, June 22, during a symposium at the American Diabetes
Association’s 84th Scientific Sessions in Orlando.
“One of the challenges of inhaled insulin adoption has been
under-dosing when converting from injectable insulin, which causes
patients to experience hyperglycemia,” said Dr. Kevin Kaiserman,
Senior Vice President, Clinical Development and Medical Affairs for
MannKind Corporation. “In this large, randomized trial utilizing
more appropriate dose conversion, we are excited to see meal
challenge results support the safety and efficacy of inhaled
insulin from the start.”
INHALE-3 is a 17-week randomized controlled trial with a 13-week
extension. The study, which enrolled 141 patients (123 randomized),
assigned participants over 18 years of age with T1D who are using
MDI, an automated insulin delivery system, or a pump without
automation to either continue their standard of care or initiate an
insulin regimen of a daily basal injection plus Afrezza for boluses
(mealtime and corrections). Subjects utilizing inhaled insulin
received a higher initial conversion dose than in the current
label. Both arms utilized continuous glucose monitoring to assess
glucose control. A1c levels were obtained at baseline, 17 and
30-weeks. For the meal challenge, the inhaled insulin group took an
inhaled insulin dose immediately prior to a standardized meal (a
240 calorie nutritional shake) whereas those using usual care used
RAA 5-15 minutes prior to the meal. More information on the
INHALE-3 study is available at:
ClinicalTrials.gov(NCT05904743).
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 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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