Afrezza® Safety and Pharmacokinetics Study in Pediatric Patients Opens Enrollment for Cohort 3
July 31 2019 - 9:00AM
MannKind Corporation (NASDAQ:MNKD) announced today that the
Afrezza® safety and pharmacokinetics study in pediatric patients is
now enrolling children 4-7 years of age (Cohort 3) and nearing
completion for Cohort 2 (8-12 years of age).
An interim review of data from individuals
participating in the second cohort shows that the single‑dose
pharmacokinetic profile of insulin levels for this age group is
consistent with the pattern seen in adults. In addition, dosing
over one month demonstrated a safety profile that was also
consistent with that observed in adults. As a result of these
findings, MannKind and the study investigators are proceeding with
enrollment of the third cohort of subjects.
This third and final cohort will study Afrezza
in children aged 4-7 years and will assess insulin levels, glucose
changes, and the short-term safety and tolerability of multiple
doses of Afrezza.
“We are very pleased that we can extend the
study to younger children who could benefit from the flexible
dosing Afrezza provides and thankful for the families and
investigators who have participated to date,” said David
Kendall, M.D., Chief Medical Officer
of MannKind.
For additional information about the study,
please contact John Krueger, Vice President, Clinical
Development, MannKind Corporation at
jkrueger@mannkindcorp.com.
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
CorporationMannKind 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 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 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 Alinaya Investor
Relations 818-661-5000 ir@mannkindcorp.com
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