MannKind Opens Enrollment of Phase 1 Trial of Treprostinil Technosphere for Pulmonary Arterial Hypertension
02 March 2018 - 8:01AM
MannKind Corporation (Nasdaq:MNKD), focused on the
development and commercialization of inhaled therapeutic products
for patients with diseases such as diabetes and pulmonary arterial
hypertension, today announced that it will initiate enrollment of
patients in a Phase 1 clinical study of Treprostinil Technosphere
(TreT) under an Investigational New Drug (IND) application filed
with the Food and Drug Administration (FDA). TreT is proposed as a
drug-device combination product for the treatment of patients with
pulmonary arterial hypertension (PAH), utilizing a small, portable,
breath-powered inhaler that is intended to simplify drug
dosing.
“We are excited to initiate enrollment of our
Phase 1 clinical study and to extend the potential application of
the Technosphere platform for unmet patient needs in a serious
chronic disease such as PAH,” said Dr. David Kendall, Chief Medical
Officer of MannKind. “We believe this study will allow for rapid
evaluation of treprostonil dosing and therapeutic use in pulmonary
arterial hypertension. If successful, this Phase 1 study will
lead to registration studies in 2019.”
The primary objective of the Phase 1 clinical
study is to investigate the safety, tolerability, and
pharmacokinetics of TreT in healthy volunteers after dosing by oral
inhalation. Secondary endpoints include the evaluation of
systemic exposure and pharmacokinetics of TreT, including dose
proportionality. For more information about the study, please visit
ClinicalTrials.gov.
About Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension (PAH) is a rare,
chronic, progressive, and ultimately fatal disease. It is
caused by the hardening and narrowing of the pulmonary arteries,
which results in abnormally high blood pressure in these arteries,
and leads, with time, to heart failure. The symptoms of PAH
include shortness of breath, dizziness and fatigue, which grow more
severe as the disease progresses. Patients with PAH have
severe restrictions on their exercise capacity, reduced quality of
life, and a shorter life expectancy. There is no cure for
PAH; currently available treatments manage the symptoms only.
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 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, including
statements regarding MannKind's ability to enroll patients in
clinical trials. Words such as "believes", "anticipates",
"plans", "expects", "intend", "will", "goal", "potential" and
similar expressions are intended to identify forward-looking
statements. These forward-looking statements are based upon the
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 these risks and
uncertainties, which include, without limitation, difficulties in
enrolling subjects in clinical trials, the results of clinical
trials, the ability to obtain regulatory approvals, and other risks
detailed in MannKind's filings with the Securities and Exchange
Commission, including the Annual Report on Form 10-K for the year
ended December 31, 2017 and subsequent periodic reports on Form
10-Q and current reports on Form 8-K. 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 AlinayaSVP, Investor
Relations818-661-5000ir@mannkindcorp.com
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