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 is launching the
INHALE-3 study to address the most important unmet need today in
adults living with T1D.
“This large study is planned to assess improvement in mealtime
glycemic control, which continues to be a serious challenge for the
majority of people living with type 1 diabetes,” said Michael
Castagna, PharmD, Chief Executive Officer of MannKind Corporation.
“INHALE-3 will study the effect of Afrezza on mealtime control,
which has a time-action profile that closely mimics that of
physiologic insulin in the first 120 minutes after a meal.”
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 MDI, an automated insulin
delivery (AID) system, or a pump without automation to either
continue their usual care or adopt an insulin regimen of basal
injections plus Afrezza. Both arms will utilize continuous glucose
monitoring to assess mealtime control and A1c levels.
“People living with diabetes deserve options and innovation that
can reduce burdens and provide impactful glucose control,” said Dr.
Irl B. Hirsch, Professor of Medicine and Diabetes Treatment and
Teaching Chair at the University of Washington. “As protocol chair
for the INHALE-3 study, I am looking forward to working with
leading clinical sites across the country to collect meaningful
data regarding the use of inhaled insulin.”
Approximately 120 patients will be randomized in the study
conducted in collaboration with the Jaeb Center for Health Research
and 20 sites across the country, including the Joslin Diabetes
Center, the Barbara Davis Center for Diabetes, the University of
Washington Diabetes Institute, Northwestern University, Mayo
Clinic, and University of North Carolina Diabetes Care Center.
For more information on INHALE-3 and the list of participating
sites, please visit:
https://clinicaltrials.gov/ct2/show/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 scope and
potential implications of a 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 continued testing of a
drug product may not yield successful results or results that are
consistent with earlier testing, 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.Important Safety
Information
Indications and Usage:
Afrezza® (insulin human) Inhalation Powder is a rapid acting
inhaled human insulin indicated to improve glycemic control in
adult patients with diabetes mellitus.
Limitations of Use: Not recommended for the
treatment of diabetic ketoacidosis, not recommended in patients who
smoke or have recently stopped smoking.
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.
|
|
Contraindications
AFREZZA is contraindicated: during episodes of hypoglycemia, in
patients with chronic lung disease (such as asthma or chronic
obstructive pulmonary disease [COPD]) because of the risk of acute
bronchospasm, and in patients with hypersensitivity to regular
human insulin or any of the excipients in AFREZZA.
Warnings and Precautions
Acute Bronchospasm: In a study of patients with
asthma whose bronchodilators were temporarily withheld for
assessment, bronchoconstriction and wheezing following AFREZZA
dosing was reported. Before initiating therapy, evaluate all
patients with a medical history, physical examination, and
spirometry (FEV1) to identify potential underlying lung disease. Do
not use in patients with chronic lung disease such as asthma or
COPD.
Hypoglycemia or Hyperglycemia with Changes in Insulin
Regimen: Glucose monitoring is essential for patients
receiving insulin therapy. Changes in insulin strength,
manufacturer, type, or method of administration may affect glycemic
control and predispose to hypoglycemia or hyperglycemia. These
changes should be made under close medical supervision and the
frequency of blood glucose monitoring should be increased. For
patients with type 2 diabetes, dosage modifications of concomitant
oral antidiabetic treatment may be needed.
Hypoglycemia: Hypoglycemia is the most common
adverse reaction associated with insulins, including AFREZZA.
Severe hypoglycemia can cause seizures, may be life-threatening, or
cause death. Hypoglycemia can impair concentration ability and
reaction time; this may place an individual and others at risk in
situations where these abilities are important (e.g., driving or
operating other machinery). Hypoglycemia can happen suddenly, and
symptoms may differ across patients and change over time in the
same patient. Patients and caregivers should be educated to
recognize and manage hypoglycemia. Self-monitoring of blood glucose
plays an essential role in the prevention and management of
hypoglycemia.
Decline in Pulmonary Function: AFREZZA causes a
decline in lung pulmonary function over time as measured by FEV1.
In clinical trials excluding patients with chronic lung disease and
lasting up to 2 years, AFREZZA-treated patients experienced a small
(40 mL) but greater FEV1 decline than comparator-treated patients.
Assess pulmonary function with spirometry at baseline, after the
first 6 months of therapy and annually thereafter even in the
absence of pulmonary symptoms. In patients who have a decline of
≥20% in FEV1 from baseline, consider discontinuing AFREZZA.
Consider more frequent lung function assessment in patients with
pulmonary symptoms, e.g., wheezing, bronchospasm, breathing
difficulties, or persistent or recurring cough. If symptoms
persist, discontinue AFREZZA.
Lung Cancer: In clinical trials, 2 cases of
lung cancer were observed in patients exposed to AFREZZA while no
cases were reported for the comparators. In both cases, a prior
history of heavy tobacco use was identified as a risk factor for
lung cancer. Two additional cases of lung cancer (squamous cell and
lung blastoma) were reported in non-smokers exposed to AFREZZA
after the trial completion. These data are insufficient to
determine whether AFREZZA has an effect on lung or respiratory
tract tumors. In patients with active lung cancer, a prior history
of lung cancer, or in patients at risk of lung cancer, consider
whether the benefits of AFREZZA use outweigh this potential
risk.
Diabetic Ketoacidosis (DKA): In clinical trials
enrolling patients with type 1 diabetes, diabetic ketoacidosis
(DKA) was more common in AFREZZA-treated patients (0.43%; n=13)
than in comparator-treated patients (0.14%; n=3). Patients with
type 1 diabetes should always use AFREZZA in combination with basal
insulin. In patients at risk for DKA, such as those with an acute
illness or infection, increase the frequency of glucose monitoring
and consider discontinuing AFREZZA and giving insulin using an
alternate route of administration.
Hypersensitivity Reactions: Severe,
life-threatening, generalized allergy, including anaphylaxis, can
occur with insulin products, including AFREZZA. If hypersensitivity
reactions occur, discontinue AFREZZA, treat per standard of care
and monitor until symptoms and signs resolve.
Hypokalemia: All insulin products, including
AFREZZA, cause a shift in potassium from the extracellular to
intracellular space, possibly leading to hypokalemia. Untreated
hypokalemia may cause respiratory paralysis, ventricular
arrhythmia, and death. Closely monitor potassium levels in patients
at risk of hypokalemia and treat if indicated.
Fluid Retention and Heart Failure with Concomitant Use
of Thiazolidinediones (TZDs): Fluid retention, which may
lead to or exacerbate heart failure, can occur with concomitant use
of TZDs and insulin. Observe these patients for signs and symptoms
of heart failure. If heart failure develops, it should be managed
according to current standards of care, and discontinuation or dose
reduction of the TZD should be considered.
Drug Interactions
Certain drugs may affect glucose metabolism, increasing the risk
of hypoglycemia or deceasing or increasing the blood glucose
lowering effect of AFREZZA. Dose adjustment and increased frequency
of blood glucose monitoring may be required. Co-administration of
beta-blockers, clonidine, guanethidine, and reserpine with AFREZZA
may reduce the signs and symptoms of hypoglycemia. For full list,
see Prescribing Information.
Adverse Reactions
The most common adverse reactions associated with AFREZZA are
hypoglycemia, cough, and throat pain or irritation.
To report SUSPECTED ADVERSE REACTIONS, contact MannKind
Corporation at 1-877-323-8505 or FDA at www.fda.gov/medwatch or
call 1-800-FDA-1088 (1-800-332-1088).
Please See Full Prescribing Information, including BOXED
WARNING, Medication Guide and Instructions for Use at
Afrezza.com/safety.
AFREZZA and MANNKIND are registered trademarks of MannKind
Corporation.
SOURCE: (1) Foster NC, Beck RW, Miller KM, et al.. State of
type 1 diabetes management and outcomes from the T1D exchange in
2016–2018. Diabetes Technol Ther. 2019; 21:66–72.
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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