MannKind Presents Positive Original Analyses of Afrezza® Clinical Data at American Diabetes Association (ADA) 80th Scienti...
June 15 2020 - 09:00AM
MannKind Corporation (Nasdaq: MNKD) announced that
new data from clinical studies of Afrezza® (insulin human)
Inhalation Powder was presented at the
American Diabetes
Association’s 80th Scientific Sessions, June 12-16, 2020.
The data presented includes:
- A comprehensive post hoc analysis
of four unique studies assessing the safe and effective
dosing of Afrezza in patients with type 1 diabetes1
(Poster 1023)
- An analysis demonstrating
treatment with Afrezza is associated with weight
loss in patients with type 2 diabetes, compared to weight
gain with injected mealtime insulin2 (Poster 1024)
- An evaluation of a comprehensive
two year safety study showing that significant changes in
FEV1 (as a measure of pulmonary function) during treatment
with Afrezza are both uncommon and generally
transient in nature3 (Oral Abstract 235)
”We are pleased to present these clinical
studies detailing the safe and effective use of Afrezza at this
year’s virtual ADA Scientific Sessions,” stated David Kendall, MD,
Chief Medical Officer MannKind. “These studies provide further
support of the effectiveness and clinical safety of Afrezza therapy
and offer important insights on effective dosing of Afrezza, the
favorable effect of Afrezza on body weight, and the improvement in
clinical outcomes possible when converting patients to Afrezza
therapy.”
Highlights of the presentations are described below. See the
appendix for presentation details.
Poster 1023: Dose
Titration and Clinical Effects of Inhaled Technosphere® Insulin
Compared with Mealtime Subcutaneous (SC) Analog Insulin Therapy in
Type 1 Diabetes (T1D)
- Ultra rapid-acting Afrezza can be
safely and effectively dosed at 1.5 to 2.0 times
that of injected mealtime insulin
- This dosing ratio appears to be
consistent across a range of A1C responses
- Afrezza’s ultra rapid-acting
profile may supersede the perceived precision of injected mealtime
insulin dosing and provides patients the ability to flexibly dose
based on glycemic response
Poster 1024: Technosphere® Insulin Added
to Basal Insulin Is Associated with Less Weight Gain than Basal
Insulin plus Insulin Aspart or Insulin Analog (aspart) 70/30
Mixture in Type 2 DM
- Patients with type 2 diabetes
treated with Afrezza showed modest weight loss
while those treated with insulin aspart or insulin aspart mix
resulted in weight gain
- The weight difference estimate
between Afrezza and insulin aspart was 1.83 pounds
- The weight difference estimate
between Afrezza and biaspart insulin was 3.17 pounds
- The effect on body weight was
independent of the magnitude of improvement in glucose control
Oral Abstract 235: Incidence of
Significant Changes in Pulmonary Function during A 2-year Study
with Inhaled Technosphere® Insulin
- Prior clinical studies have shown a
modest (~40 ml) difference in mean change in FEV1 over two years
when comparing treatment with Afrezza to other diabetes
therapies
- The majority (88%) of individuals
treated with Afrezza had no significant change in FEV1 measured at
any time
- Overall, 98% of patients on
Afrezza (vs. 99% of usual care) had either no
significant change (≥15%) or were observed to have
only a transient change in FEV1 over the two years
of study
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 www.afrezza.com.
About MannKind Corporation
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 ultra
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. For a discussion
of these and other factors, please refer to MannKind’s annual
report on Form 10-K for the year ended December 31, 2019 as
well as MannKind’s other filings with the SEC. 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: Investor Relations
818-661-5000 ir@mannkindcorp.com
Appendix – Presentation Details(1) Poster
Presentation: Dose Titration and Clinical Effects of Inhaled
Technosphere® Insulin Compared with Mealtime Subcutaneous (SC)
Analog Insulin Therapy in Type 1 Diabetes (T1D)Presenter: David M.
Kendall, M.D. Poster No. 1023-P Date/Time: Saturday, June 13; 10 AM
CT
(2) Poster Presentation: Technosphere® Insulin Added to Basal
Insulin Is Associated with Less Weight Gain than Basal Insulin plus
Insulin Aspart or Insulin Analog (aspart) 70/30 Mixture in Type 2
DMPresenter: David M. Kendall, M.D. Poster No: 1024-P Date/Time:
Saturday, June 13; 10 AM CT
(3) Oral Presentation: Incidence of Significant Changes in
Pulmonary Function during A 2-year Study with Inhaled Technosphere®
Insulin Presenter: David M. Kendall, M.D. Poster No: 235-OR
Date/Time: Sunday, June 14; 5:30 PM CT
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