MannKind Presents Positive Afrezza® Clinical Data from Three Studies at ADA 79th Scientific Sessions
June 09 2019 - 2:00PM
MannKind Corporation (Nasdaq: MNKD) announced that
new data from three different studies of Afrezza® (insulin human)
Inhalation Powder were released at the American Diabetes
Association’s 79th Scientific Sessions, being held June
7-11, in San Francisco, California.
Poster 1350-P:
Safety and Pharmacokinetics of Technosphere Insulin in
Pediatric Patients
MannKind will present a poster with initial
information from its ongoing study of Safety and Pharmacokinetics
of Technosphere Insulin (Afrezza) in Pediatric Patients ¹ on
Monday, June 10. This study is the first step in preparation
for a phase 3 safety and efficacy study.
Poster
Highlights:
- In pediatric patients, the rapid rise in insulin concentrations
corresponded with early postprandial glucose control within the
first hour post-dose. The profile is similar to that previously
observed in adults.
- Consistent with its safety profile in adults, Afrezza was
generally well-tolerated in pediatric patients; most treatment
emergent adverse events were of mild severity, and no severe
hypoglycemia was observed.
- These data will help guide the finalization of the protocol for
a phase 3 safety and efficacy study.
“We are excited to share the progress of the
ongoing pediatric study program,” said David Kendall,
M.D., Chief Medical Officer of MannKind. “As is well
known, type 1 diabetes is often diagnosed in children and
adolescents, and these individuals will continue to require insulin
therapy throughout their lives. Evaluating as quickly as possible
the potential use of Afrezza in children and adolescents as an
option for mealtime insulin therapy is a top priority for
MannKind.”
Poster 136-LB: Effective
Treatment of T2D Patients Uncontrolled on Multiple Diabetes
Medications by Adding Afrezza® Mealtime Ultra-Rapid
Insulin
Dr. Philip Levin and colleagues presented data
from an independent study supported and funded by MannKind. Dr.
Levin presented late-breaking clinical data on interim results of a
study² showing how a fixed titration schedule can be implemented to
achieve better time in range and reduction of overall A1c.
Late Breaking Poster Highlights:
- Enrolled adult patients with uncontrolled type 2 diabetes on
two or more therapies (orals/ basal/ GLPs) – with the addition of
Afrezza at all meals by means of a rapid and ongoing titration
protocol
- Observed a mean decrease in A1c of ~1.6% (all subjects with A1c
reduction over 12 weeks of study)
- 93% (13 of 14 subjects) achieved A1c below 8% (mean baseline
A1c 9.1%)
- Reduced hyperglycemia (>250mg/dL) by 74%
- Increased time in range more than 75%; daily glucose decreased
by ~50 mg/dL as measured by blinded continuous glucose
monitoring
- No significant difference in rates of hypoglycemia with the
addition of Afrezza
“We are pleased to share the interim analysis
from our independent investigator-initiated trial of Afrezza
therapy. These preliminary data significantly advance our
understanding of the potential clinical benefits and practical use
of Afrezza therapy for those living with type 2 diabetes,”
stated Philip Levin, M.D. of Bay West Endocrinology Associates
and MODEL Clinical Research in Baltimore, MD. “Data generated to
this point are encouraging and support the use of Afrezza as
prandial therapy earlier in the treatment of type 2 diabetes.”
Oral Abstract 151-OR:
Technosphere Insulin Provides Better Early Postprandial Glucose
Control than Subcutaneous Rapid-Acting Analog
MannKind investigators also shared data at an
oral presentation³ using mixed meal tolerance testing to assess
glucose control, Afrezza dosing and overall safety in a cohort of
individuals with type 1 diabetes.
Oral Presentation
Highlights:
- When compared to rapid acting injected insulin, Afrezza
provided significantly better glucose control in the first two
hours following the meal.
- Even when adjusting the dose of Afrezza using up to two times
the dose of injected insulin aspart, Afrezza treatment was
associated with lower rates of overall and level 2 hypoglycemia -
an observation that was particularly evident in the late (>2
hour) post-meal period.
Dr. Anne Peters, Clinical Professor of Medicine
at the Keck School of Medicine at USC and Director of the USC
Westside Center for Diabetes Care noted that “the improved
post-meal glucose levels and lower rates of low blood sugars seen
in this study of individuals with type 1 diabetes support my
growing clinical experience. The presentation of these data
provides further evidence that proper dosing of Afrezza has the
potential to safely and effectively get more patients into target
range at meal times.”
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 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 orally
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 quarterly
report on Form 10-Q for the quarter ended March 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:Rose
AlinayaInvestor Relations818-661-5000ir@mannkindcorp.com
Appendix – Poster Information
(1) Poster Presentation: Safety and
Pharmacokinetics of Technosphere Insulin (TI) in Pediatric
PatientsPresenter:
David M. Kendall, M.D.Poster
No.
1350-PDate/Time:
Monday, June 10; 12:00 PM - 1:00 PM, Hall F (North, Exhibition
Level)
(2) Late-Breaking Poster Presentation: Effective
Treatment of T2D Patients Uncontrolled on Multiple Diabetes
Medications by Adding Afrezza Mealtime Ultra-Rapid
InsulinPresenter:
Philip Levin, M.D.Poster No:
136-LB (late breaking
poster)Date/Time:
Sunday, June 9; 12:00 PM - 1:00 PM, Hall F (North, Exhibition
Level)
(3) Oral Presentation: Technosphere Insulin
Provides Better Early Postprandial Glucose Control than
Subcutaneous Rapid-Acting Analog
Presenter:
David M. Kendall, M.D.Poster No:
151-OR
Date/Time: Sunday,
June 9; 9:45 AM
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