MannKind Presents Positive Afrezza® STAT Study Clinical Data at 54th Annual Meeting of the European Association for the Stud...
October 04 2018 - 9:00AM
Poster 813; PS 068 Improved
post-prandial blood glucose excursions with Technosphere inhaled
insulin compared to aspart in adult patients with type 1 diabetes:
STAT study intention to treat analysis
MannKind Corporation (Nasdaq:MNKD), a company focused on the
development and commercialization of inhaled therapeutic products
for patients with diseases such as diabetes and pulmonary arterial
hypertension, presented data from the STAT study
(
STudy comparing prandial
insulin
Aspart
vs.
Technosphere insulin in patients with
type 1 diabetes on multiple daily injections) at the 54th Annual
Meeting of the European Association for the Study of Diabetes
(EASD) in Berlin, Germany. The STAT study is the first
randomized, controlled study to assess diabetes control using
continuous glucose monitoring (CGM) and Afrezza® in individuals
with type 1 diabetes. The dual primary endpoints were an assessment
of glucose time-in-range (TIR) as well as post-prandial glucose
excursions (PPGE) in the 1-4 hour post-meal period. The two poster
presentations took place on Tuesday, October 2, 2018 (poster 813;
PS 068) and Wednesday, October 3, 2018 (poster 677; PS 051).
“We continue to advance the understanding of the
potential clinical benefits of Afrezza by sharing the positive data
from the STAT study at the 2018 EASD conference,” said David
Kendall, M.D., Chief Medical Officer of MannKind Corporation.
“These data highlight the potential clinical benefits that Afrezza
offers individuals living with type 1 diabetes in managing their
glucose levels, and support our belief that Afrezza is more
effective than insulin aspart in improving post-prandial glucose
(PPG) control for type 1 diabetes patients. Further, the STAT study
results offer important insights into ways that individuals with
diabetes can potentially improve their experience and outcomes by
using mealtime inhaled insulin, and support the view that Afrezza
has the potential to be the treatment of choice for those
individuals with diabetes who require alternatives that further
improve mealtime glucose control.”
Afrezza STAT Study Poster Presentations
at EASD
Title: |
Improved
Post-prandial Blood Glucose Excursions with Technosphere Inhaled
Insulin Compared to Aspart in Adult Patients with Type 1 Diabetes:
STAT Study Intention to Treat Analysis (poster 813; PS
068) |
|
|
Presenter: |
Halis K.
Akturk, M.D. |
|
|
Highlights: |
- Technosphere Insulin (Afrezza) significantly improved
post-prandial blood glucose (PPBG) at 60 and 90 minutes
- Afrezza significantly decreased PPGE at breakfast and
lunch
- Afrezza improved daytime TIR and significantly decreased
glucose variability
- Time spent in hypoglycemia defined as <60 mg/dL and < 50
mg/dL was significantly less with Afrezza vs insulin aspart,
respectively
|
Conclusion: |
Afrezza,
when administered at the beginning of a meal, and supplemented at
appropriate post meal intervals as needed, significantly improved
PPGE and improved TIR when compared with insulin aspart in adult
patients with type 1 diabetes. |
|
|
Title: |
Improved Time-in-Range on Continuous Glucose Monitor with
Technosphere Insulin Compared to Insulin Aspart in Adults with Type
1 Diabetes: STAT study Per Protocol Analysis (poster 677;
PS 051) |
|
|
Presenter: |
Janet
Snell-Bergeon, Ph.D. |
|
|
Highlights: |
- Afrezza improved PPG as well as all-day glucose TIR when
additional post-prandial TI doses were taken as needed
- Afrezza decreased PPGE, 2-hour glucose area under the curve and
daytime glucose variability when taken per protocol (additional
doses 1hour – 2hour post-meal as needed)
- There was no increase in hypoglycemia with the use of TI when
compared with aspart
|
Conclusion: |
The use
of Afrezza, with proper supplemental dosing per protocol,
significantly improved 24 hour TIR and lowered PPGE (1-4 hours)
when compared to insulin aspart. In addition, these data suggest
that Afrezza can reduce time in hypoglycemia in adult patients with
type 1 diabetes when compared to aspart. |
“We are very pleased to have the opportunity to
present results of the STAT study at EASD,” said Michael Castagna,
Chief Executive Officer of MannKind Corporation. “The International
Diabetes Federation estimates that approximately 425 million people
are living with diabetes worldwide, including 58 million in Europe.
It's a chance for those living with diabetes in this part of the
world to learn more about rapid-acting mealtime insulin and,
hopefully one day, extend the potential opportunity for this
population with diabetes to manage their disease with our novel
mealtime insulin.”
About Afrezza®Available by
prescription, Afrezza® (insulin human) Inhalation Powder is a
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 about 12 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 on Afrezza, please visit www.afrezza.com.
About MannKind
CorporationMannKind Corporation (NASDAQ:MNKD)
focuses on the development and commercialization of inhaled
therapeutic products for patients with diseases such as diabetes
and pulmonary arterial hypertension. MannKind is
currently commercializing Afrezza® (insulin human) Inhalation
Powder, the Company's first FDA-approved product and the only
inhaled rapid-acting mealtime insulin in the United States,
where it is available by prescription from pharmacies
nationwide. MannKind is headquartered in Westlake
Village, California, and has a state-of-the art manufacturing
facility in Danbury, Connecticut. The Company also employs
field sales and medical representatives across the U.S. For further
information, visit www.mannkindcorp.com.
Forward-Looking
StatementsThis press release contains
forward-looking statements that involve 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 detailed in MannKind's filings with
the SEC, including its annual report on Form 10-K for the year
ended December 31, 2017. 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.
Company
Contact: Rose Alinaya SVP,
Investor Relations 818-661-5000 ir@mannkindcorp.com
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