WESTLAKE VILLAGE, Calif.,
June 25, 2021 /PRNewswire/
-- MannKind Corporation (Nasdaq: MNKD), which
focuses on the development of innovative medicines for patients
with endocrine and orphan lung diseases, will present two posters
at the American Diabetes Association's virtual 81st
Scientific Sessions, June 25-29. The submissions include
923-P in Pediatrics-Type 1 Diabetes, and 722-P in Clinical
Therapeutics/New Technology-Insulins. MannKind is also
hosting a booth in the virtual Exhibit Hall at the Scientific
Sessions.
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Poster 923-P
An insulin regimen that closely mimics physiologic insulin for
pediatric patients with type 1 diabetes (T1D) remains a critical
goal. Poster 923-P reports on a Phase 2 clinical study to
characterize the pharmacokinetics (PK) and safety of prandial
Afrezza® (Technosphere® Insulin or TI) in 30
children aged 8 to 17 years with T1D. Afrezza – an ultra
rapid-acting dry-powder prandial insulin – is currently indicated
to improve glycemic control in adults with T1D or type 2 (T2D)
diabetes.
"The final results from the phase 2 pediatric study revealed
that serum insulin concentrations peaked rapidly within 10-15
minutes of inhaled administration of TI, similar to the results
observed previously in adults. In addition, there were no
severe hypoglycemic events or clinically relevant declines in
pulmonary function, and no new or unexpected signals with TI," said
Dr. Kevin Kaiserman, Vice President,
Medical Affairs and Safety of MannKind and the presenting author of
the study. "The pharmacokinetics and safety results provide us the
rationale to move forward with conducting a phase 3 safety and
efficacy study in pediatric patients with diabetes, which we expect
to initiate in the fall."
PK measurements were obtained in 30 patients with T1D (median
age of 12.7 years). Patients met criteria of using insulin for at
least one year, and were on a stable regimen of basal-bolus insulin
therapy for six weeks or greater. Insulin PK and blood glucose were
assessed following single doses of TI.
Poster 722-P
Poster 722-P presents a retrospective analysis of data from the
Levin study, an investigator-initiated trial sponsored by MannKind,
to determine the effect of prandial inhaled insulin on daytime
glucose levels in people with uncontrolled type 2 diabetes.
For purposes of the study, daytime was defined as 6:00 am to midnight.
- Twenty T2D patients who had never been on mealtime insulin
before were started on TI and rapidly titrated during the first
week and followed for 12 weeks.
- On average, patients showed an 83.5% increase in daytime
time-in-range (70-180 mg/dL).
- The study concluded that TI reduced patients' daytime time
spent in hyperglycemia (>250 mg/dl) by 76.4% (p=0.0002) and
without a significant increase in daytime time spent in
hypoglycemia (<54 mg/dl) (p=0.0938).
"Daytime time-in-range continues to be the most challenging
aspect of living with diabetes," said Dr. Philip Levin. "The data demonstrated that adding
mealtime insulin helped decrease time spent in hyperglycemia and
improved glycemic control for patients with T2D."
About Afrezza®
Available by prescription,
Afrezza® (insulin human) Inhalation Powder is an ultra
rapid-acting inhaled insulin indicated to improve glycemic control
in adult patients with diabetes mellitus. Afrezza consists of a dry
powder formulation of human insulin delivered from a small and
portable inhaler. Administered at the beginning of a meal, Afrezza
dissolves rapidly upon inhalation to the lung and passes quickly
into the bloodstream (in less than one minute). This rapid
absorption allows Afrezza to begin reducing blood sugar levels
within minutes of administration. Afrezza is available in 4-unit,
8-unit and 12-unit single-dose cartridges of insulin powder that
can be used, as prescribed by a health care professional, in
combination with other diabetes medications to achieve target blood
sugar levels. For Afrezza doses exceeding 12 units, patients may
use a combination of existing cartridge strengths. For more
information about Afrezza, please visit afrezza.com.
About MannKind Corporation
MannKind Corporation
(Nasdaq: MNKD) focuses on the development and commercialization of
inhaled therapeutic products for patients with endocrine and orphan
lung diseases. MannKind is currently commercializing
Afrezza® (insulin human) Inhalation Powder, the
Company's first FDA-approved product and the only inhaled
ultra-rapid-acting mealtime insulin in the United States, where it is available by
prescription from pharmacies nationwide. Afrezza is also
available by prescription in Brazil, where it is commercialized by the
Company's partner, Biomm SA. MannKind was established in 1991,
and is headquartered in Westlake Village,
Calif., with a manufacturing and R&D facility based in
Danbury, Conn. The Company also employs field sales and
medical representatives across the U.S. Please visit
mannkindcorp.com to learn more.
AFREZZA and TECHNOSPHERE are registered trademarks of MannKind
Corporation.
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