Additional Positive Afrezza® Clinical Data from STAT Study To Be Presented at ADA 78th Scientific Sessions
June 25 2018 - 8:00AM
Oral presentation (348-OR) at 5:00 pm today
MannKind Corporation (Nasdaq:MNKD) announced that additional 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) will be presented in an oral
presentation later today at the American Diabetes Association’s
(ADA) 78th Scientific Sessions. 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
post-prandial glucose (PPG) excursions in the 1-4 hour post-meal
period. Time-in-range results were presented in a poster
presentation on Saturday, June 23, 2018.
STAT Study Oral Presentation Highlights
Title: |
Study Comparing Prandial Insulin Aspart vs. Technosphere
Insulin (TI) in Patients with Type 1 Diabetes on Multiple Daily
Injections: STAT Study |
Presenter: |
Satish Garg, M.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 lowered PPG values at 1 and 2 hours after meals
(-38.2 and -17.9 mg/dl, respectively) as measured by CGM |
|
• |
Significantly reduced overall PPG excursions (i.e., the peak
increase in CGM glucose during the 1-4 hour post-meal period) by
15%. In addition, |
|
|
o |
a 15%
reduction in overall PPG excursions was also seen in Afrezza
subjects who dosed at mealtimes only and did not follow the
supplemental dosing protocol |
|
|
o |
PPG
excursions were significantly reduced following breakfast
(approximately 20%) and lunch (approximately 25%) (based on an
analysis of all subjects in the Afrezza group without regard to
their adherence to the supplemental dosing protocol) |
|
• |
Significantly improved all-day glucose time-in-range by an
average of 1.5 hours, or 12% |
Conclusion: |
Afrezza may provide greater improvement in PPG control than
insulin aspart |
“I am very pleased to have led the novel STAT
trial, performed as a collaborative trial with several other
investigators at the Barbara Davis Diabetes Center as well as four
other sites around the country. This study shows that the use of
Afrezza at mealtimes, and as needed following meals, provides
significant improvement in postprandial glucose (PPG) when compared
to mealtime insulin aspart in Type 1 diabetes patients who are
using continuous glucose monitoring,” stated Halis Kaan Akturk,
M.D., Assistant Professor of Medicine and Pediatrics, Barbara Davis
Center for Diabetes, University of Colorado Denver and the
principal investigator of the STAT study.
“These new data presented at the ADA’s 78th
Scientific Sessions significantly advance our understanding of the
potential clinical benefits of Afrezza for those living with Type 1
diabetes,” stated Michael Castagna, Chief Executive Officer of
MannKind. “We believe the last frontier for driving better outcomes
for people living with diabetes is the ability to control mealtime
glucose levels. Based on the data generated to date, we believe
that Afrezza – with its ability to lower HbA1c levels without the
same degree of concomitant risk of hypoglycemia as other mealtime
insulins – has the potential to be the treatment of choice for
those individuals with diabetes requiring mealtime glucose
control.”
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 MannKindMannKind 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.
MannKind Contact:Rose Alinaya SVP, Investor
Relations 818-661-5000 ir@mannkindcorp.com
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