MannKind Presents Novel Scientific Data at 13th International Conference on Advanced Technologies & Treatments for Diabetes (...
February 20 2020 - 9:00AM
MannKind Corporation (NASDAQ:
MNKD) today announced the presentation of results
from multiple clinical studies of Afrezza® (insulin human)
Inhalation Powder and MannKind’s BluHale® technology system. These
data are being presented in both oral and poster presentations
during the 13th International Conference on
Advanced
Technologies & Treatments for Diabetes (ATTD
2020) in Madrid Spain, February 20-22, 2020.
“We are very pleased to have the opportunity to
highlight these positive results during this year’s ATTD,” stated
Dr. David Kendall, Chief Medical Officer of MannKind.
“These presentations highlight original studies of Afrezza in
individuals with both type 1 and type 2 diabetes, and include
initial studies of Afrezza in pediatric patients. In addition to
the results of clinical studies, we are pleased to disclose novel
data on the use of BluHale, our Bluetooth-enabled technology for
real-time profiling of inhalation effort and other parameters
associated with the use of our inhaler. Collectively, these data
further expand our understanding of the unique clinical profile of
Afrezza, and highlight the potential use of Afrezza in children and
adolescents, as well as advancing the opportunity to create
connected technology for our drug delivery system.”
Highlights of the original scientific
disclosures:
- Preliminary data from an
independent, investigator initiated study of Afrezza on the
background of closed loop pump insulin delivery by means of an
“artificial pancreas” system showed that pulmonary dosing allows
for titration to higher unit doses in individuals with type 1
diabetes (presented by Alfonso Galderisi MD, PhD from Yale
University).
- Clinical use of Afrezza in adults
with uncontrolled type 2 diabetes on two or more glucose lowering
therapies resulted in a significant (1.6%) drop in A1c levels and a
significant increase in time in range (presented by Dr. Philip
Levin MD, Endocrinology, MODEL Clinical Research).
- Pharmacokinetics (and
pharmacodynamics) of Technosphere insulin in children and
adolescents ages 8-17 with type 1 diabetes showed that the ultra
rapid rise in insulin concentrations corresponded with early
post-prandial glucose control within the first hour post-dose,
similar to what has been observed in adult patients.
- Two poster presentations
highlighting the use of MannKind’s unique Bluetooth enabled
technology for enhanced instruction on use of the Afrezza inhaler
and as a tool to provide connected dose information on top of
continuous glucose monitoring data.
Dr. Phillip Levin, Principal Investigator from
MODEL Clinical Research in Baltimore, MD and lead author on the
study of uncontrolled type 2 diabetes patients, noted that “the
addition and rapid titration of Afrezza in patients with type 2
diabetes not currently at goal using two or more glucose lowering
therapies, resulted in a 1.6% reduction in A1C and significantly
increased time in range as measured by CGM. Our study provides
additional clarity on both dose requirements and the clinical
impact of adding ultra rapid-acting Afrezza therapy in uncontrolled
type 2 diabetes.”
In addition to the original scientific
disclosure presented at this year’s ATTD meeting, Dr. Kendall will
participate as faculty in the “Ultra-rapid Insulin Analogues”
session on Saturday, February 22, during which he will provide a
current perspective on the clinical use of Afrezza, including
evidence that ultra rapid-acting Afrezza can be safely and
effectively titrated in fixed dose increments and that speed of
insulin action may supersede dose precision for achieving
post-prandial glucose control.
The full title of each of the presentations, presenting author,
and the date and time of each disclosure are provided below.
ORAL PRESENTATION HIGHLIGHTS |
|
|
Title: |
Technosphere® Insulin Provides Better Early Postprandial
Glucose Control Than Subcutaneous Rapid-Acting Analogue (ATTD 2020
- Saturday February 22, 2020; 8:50 – 9:00 a.m. – Berlin Room) |
|
|
Presenter: |
David Kendall, MD, MannKind Corporation |
|
|
ELECTRONIC POSTER PRESENTATION
HIGHLIGHTS |
|
|
Title: |
Patient Trainer Experience with BluHale® V1.0 for Proper
Technosphere® Insulin Administration (ATTD 2020 – Thursday,
February 20, 2020; 8 a.m.) |
|
|
Presenter: |
Nadia Zaveri, PharmD, MannKind Corporation |
|
|
|
|
Title: |
Safety and Pharmacokinetics of Technosphere® Insulin in
Pediatric Patients(ATTD 2020 – Thursday, February 20, 2020; 8
a.m.) |
|
|
Presenter: |
David Kendall, MD, MannKind Corporation |
|
|
|
|
Title: |
Insights to Improve Use of Technosphere® Insulin Provided By
BluHale®, a Digital Diabetes Tool (ATTD 2020 – Thursday, February
20, 2020; 8 a.m.) |
|
|
Presenter: |
Benoit Adamo, MannKind Corporation |
|
|
|
|
Title: |
Effective Treatment of Patients with Uncontrolled Type 2
Diabetes On Multiple Diabetes Medications By Adding Mealtime
Ultra-rapid Technosphere® Insulin(ATTD 2020 – Thursday, February
20, 2020; 8 a.m.) |
|
|
Presenter: |
Philip Levin, MD, Endocrinology, MODEL Clinical Research |
|
|
|
|
Title: |
Afrezza® Pre-meal Bolus Reduces Early Glycemic Excursion During
Hybrid Closed Loop Treatment (ATTD 2020 – Saturday, February 22,
2020; 8:30 a.m.) |
|
|
Presenter: |
Alfonso Galderisi, MD, PhD, Yale University |
About ATTD Annual MeetingThe
ATTD is a scientific program that brings leading international
experts together to discuss breakthroughs in diabetes treatments,
technological innovations and showcase the latest developments in
new insulin analogues, delivery systems, pumps, glucose sensors,
closed-loop systems and much more.
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 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 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 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. For a discussion of these and other factors, please
refer to MannKind’s quarterly report on Form 10-Q for the quarter
ended September 30, 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: 818-661-5000
ir@mannkindcorp.com
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