MannKind Presents Positive Afrezza® Clinical Data from STAT and AFFINITY Studies at ADA 78th Scientific Sessions
June 23 2018 - 10:00AM
Poster 1017-P: Afrezza provides improved
Time-in-Range on Continuous Glucose Monitoring compared to insulin
aspart
MannKind Corporation (Nasdaq:MNKD) announced that new data
for Afrezza from the STAT study (
STudy comparing
prandial insulin
Aspart vs.
Technosphere insulin in patients with Type 1
diabetes on multiple daily injections) were released today at the
American Diabetes Association’s 78th Scientific Sessions, being
held June 22-26, 2018, in Orlando, Florida. The STAT study involved
60 patients with Type 1 diabetes and is the first randomized,
controlled study to use continuous glucose monitoring (CGM) with
Afrezza. The dual primary endpoints were assessment of glucose
time-in-range and postprandial glucose (PPG) excursions in the 1-4
hour post-meal period. PPG control results from this study
will be presented as an oral presentation on Monday June 25th, 2018
in Session 348-OR.
STAT Study Poster
Highlights:
Title: |
|
Improved Time-in-Range
(TIR) on Continuous Glucose Monitor (CGM) with Technosphere Inhaled
Insulin (TI) compared to insulin Aspart in Patients with T1D—STAT
Study |
Presenter: |
|
Janet-Snell-Bergeon,
Ph.D. |
Highlights: |
|
Compared to insulin
aspart, the per-protocol use of Afrezza (i.e., with supplemental
doses 1 and/or 2 hours post-meal):
- Significantly improved all-day glucose time-in-range by an
average of 1.5 hours, or 12%
- Significantly decreased daytime glucose variability by 17%
- Significantly reduced the time spent in hypoglycemia (i.e.,
<70 mg/dl) by 41% or approximately 23 minutes per day
|
Conclusion: |
|
The faster action with
shorter duration profile of Afrezza when compared to rapid-acting
insulin analogs may provide a flexible approach for patients to
optimize post-prandial glucose control without increasing risk of
hypoglycemia |
“We are very pleased to present results of the
novel STAT trial. This is the first time we have seen a
rapid-acting mealtime insulin provide a superior outcome when
utilized with CGM in a treat-to-target dosing strategy. The results
demonstrated that Afrezza dosed before and (as needed) after meals
significantly improved all-day glucose time-in-range, limited
daytime glucose variability and significantly reduced the overall
rate and time spent in hypoglycemia,” stated David Kendall, M.D.,
Chief Medical Officer of MannKind Corporation.
MannKind also presented a late-breaking poster
presenting a post-hoc analysis of a representative subset of the
AFFINITY 1 study that demonstrated the use of Afrezza significantly
lowers the rate of hypoglycemia in patients with Type 1 diabetes
while providing non-inferior glycemic control.
Affinity-1 Late Breaking Poster Highlights:
Title: |
|
Total and Severe
Hypoglycemia is Reduced With Use of Inhaled Technosphere® Insulin
(AFREZZA®) Relative to Insulin Aspart in Type 1 Diabetes |
Presenter: |
|
Lawrence Blonde |
Highlights: |
|
Compared
to insulin aspart:
- Use of Afrezza significantly lowers the rate of hypoglycemia in
Type 1 diabetes while providing similar or better glycemic control
(54.1 events per subject vs. 78.2 events per subject, a reduction
of 31%)
- On average, 26% lower rates of hypoglycemia were observed with
Afrezza across the range of HbA1c levels, allowing the same degree
of glycemic control with less hypoglycemia than insulin
aspart. For example,
- a patient with an HbA1c of 8.0% on insulin aspart would
experience the same rate of hypoglycemia (12.2 events per month) as
a patient on Afrezza with an HbA1c of 6.8% (ΔHbA1c =
-1.2%)
- Alternatively, patients with HbA1c of 6.8% on Afrezza would be
estimated to experience 4 fewer hypoglycemic events per month than
a similar patient on insulin aspart
|
Conclusion: |
|
Use of Afrezza in a
multi-dose insulin regimen may permit treatment intensification to
be achieved with less hypoglycemia. Switching to Afrezza may
also benefit patients already at goal by reducing the frequency of
hypoglycemia events. |
“The late breaking poster presentation, from a
post-hoc regression analysis of a representative subset of the
AFFINITY 1 study patient, evaluated overall and severe hypoglycemia
event rates with AFREZZA relative to insulin aspart in Type 1
diabetes patients. This analysis, which controlled for a number of
variables that can impact glucose control and rates of
hypoglycemia, demonstrated that use of Afrezza resulted in
significantly lower rates of hypoglycemia in Type 1 diabetes
patients across a wide range of HbA1c as compared to insulin
aspart. Hypoglycemia remains one of the major factors that
limit to the ability of healthcare providers and patients to
intensify insulin therapy and can further limit the ability to
achieve optimal glucose control,” continued Dr. Kendall.
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
MannKind 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 Statements
This 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.
MannKind Contact:Rose Alinaya SVP, Investor
Relations 818-661-5000 ir@mannkindcorp.com
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