LEXINGTON, Mass., Sept. 18, 2019 /PRNewswire/ -- Pulmatrix,
Inc. (NASDAQ: PULM) today announced that the first patient has
been dosed in the Phase 2 trial evaluating Pulmazole, an inhaled
iSPERSE formulation of the antifungal itraconazole in development
for the treatment of Allergic Bronchopulmonary Aspergillosis (ABPA)
in patients with asthma. The randomized, double-blind,
placebo-controlled trial will evaluate the efficacy and safety of
three dose levels of Pulmazole administered daily for 28 days in
approximately 64 patients.
"Building upon the Phase 1 results, in which Pulmazole achieved
greater drug concentrations in the lung with much lower plasma
concentrations than oral Sporanox at 1/10th the dose,
the dosing of our first Phase 2 Study patient is an important
milestone," said Ted Raad, chief
executive officer of Pulmatrix. "We believe that Pulmazole
has the potential to change the standard of care for patients with
ABPA and asthma by providing a treatment option that prevents the
dose-limiting side effects seen with oral antifungal treatments and
improves upon the known efficacy of oral itraconazole by delivering
significantly more drug to the lungs than can be achieved with oral
dosing."
The Phase 2 study is a global, multicenter, 4 arm trial.
Enrolled subjects will be randomly assigned (1:1:1:1) into 4 arms
of 16 subjects each (n=64 total) and will receive 10 mg, 20 mg, or
35 mg of Pulmazole or placebo, administered via once daily dry
powder inhalation daily for 28 days. The primary objective of
the study is to evaluate the safety and tolerability of
multiple-dose administration of Pulmazole given to adult subjects
with asthma and ABPA. Secondary objectives include
characterizing the pharmacokinetics of multiple dose administration
of inhaled Pulmazole in plasma and sputum, as well as evaluating
the effect of Pulmazole on relevant biomarkers of inflammation,
pulmonary function (FEV1), asthma symptoms, and
aspergillus burden in sputum.
About Allergic Bronchopulmonary Aspergillosis
(ABPA)
Allergic bronchopulmonary aspergillosis (ABPA) is an
exaggerated response of the immune system to the fungus
Aspergillus fumigatus in patients with asthma and
cystic fibrosis. Aspergillus, a ubiquitous fungus, colonizes the
airways of patients with asthma and cystic fibrosis and triggers an
intense inflammatory response that results in worsening symptoms,
more frequent exacerbations, and ultimately lung damage. Current
treatment for ABPA consists of prolonged courses of oral
corticosteroids, and oral antifungal therapy is added in patients
who do not respond adequately to oral corticosteroid therapy alone.
Published studies evaluating antifungal agents in patients with
ABPA report some degree of improved disease control leading to the
reduction of oral corticosteroid dose. However, the use of oral
antifungal therapy is limited by systemic side effects and poor
bioavailability in the airways. ABPA is estimated to occur in
approximately 1.5% of adult patients with asthma, with about
300,000 affected individuals in the US and approximately 5 million
patients with asthma worldwide.
About Pulmatrix
Pulmatrix is a clinical stage
biopharmaceutical company developing innovative inhaled therapies
to address serious pulmonary disease using its patented iSPERSE™
technology. The Company's proprietary product pipeline is focused
on advancing treatments for serious lung diseases, including
Pulmazole, an inhaled anti-fungal for patients with allergic
bronchopulmonary aspergillosis ("ABPA"), and PUR1800, a narrow
spectrum kinase inhibitor for patients with obstructive lung
diseases including asthma and chronic obstructive pulmonary disease
("COPD"). Pulmatrix's product candidates are based on iSPERSE™, its
proprietary engineered dry powder delivery platform, which seeks to
improve therapeutic delivery to the lungs by maximizing local
concentrations and reducing systemic side effects to improve
patient outcomes.
FORWARD-LOOKING STATEMENTS
Certain statements in this
press release that are forward-looking and not statements of
historical fact are forward-looking statements within the meaning
of the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Such forward-looking statements include, but
are not limited to, statements of historical fact, and may be
identified by words such as "anticipates," "assumes," "believes,"
"can," "could," "estimates," "expects," "forecasts," "guides,"
"intends," "is confident that", "may," "plans," "seeks,"
"projects," "targets," and "would," and their opposites and similar
expressions are intended to identify forward-looking statements.
Such forward-looking statements are based on the beliefs of
management as well as assumptions made by and information currently
available to management. Actual results could differ materially
from those contemplated by the forward-looking statements as a
result of certain factors, including, but not limited to, delays in
planned clinical trials; the ability to establish that potential
products are efficacious or safe in preclinical or clinical trials;
the ability to establish or maintain collaborations on the
development of therapeutic candidates; the ability to obtain
appropriate or necessary governmental approvals to market potential
products; the ability to obtain future funding for developmental
products and working capital and to obtain such funding on
commercially reasonable terms; the Company's ability to manufacture
product candidates on a commercial scale or in collaborations with
third parties; changes in the size and nature of competitors; the
ability to retain key executives and scientists; and the ability to
secure and enforce legal rights related to the Company's products,
including patent protection. A discussion of these and other
factors, including risks and uncertainties with respect to the
Company, is set forth in the Company's filings with the SEC,
including its annual report on Form 10-K filed with the Securities
and Exchange Commission on February 19,
2019, as amended on July 24,
2019, as may be supplemented or amended by the Company's
Quarterly Reports on Form 10-Q. The Company disclaims any intention
or obligation to revise any forward-looking statements, whether as
a result of new information, future events or otherwise, except as
required by law.
Investor
Contact
|
|
Ted Raad,
CEO
|
William Duke,
CFO
|
(781)
357-2333
|
(781)
357-2333
|
traad@pulmatrix.com
|
wduke@pulmatrix.com
|
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SOURCE Pulmatrix, Inc.