LEXINGTON, Mass., Oct. 3, 2017 /PRNewswire/ -- Pulmatrix, Inc.
(NASDAQ: PULM), a clinical stage biopharmaceutical company
developing innovative inhaled therapies to address serious
pulmonary diseases, today announced that its drug candidate for
treating fungal infections in the lungs, Pulmazole (PUR1900), has
been designated as a "Qualified Infectious Disease Product" (QIDP)
in a second indication by the U.S. Food & Drug
Administration.
Under the QIDP program, which is designed to speed the
development of novel drugs against important pathogens, Pulmatrix
will receive five years of additional market exclusivity for
Pulmazole (PUR1900). Pulmatrix had previously received
QIDP status as well as orphan drug designation from the FDA for
Pulmazole (PUR1900) to treat fungal infections in the airways of
patients with cystic fibrosis, a rare genetic disease estimated to
affect 75,000-100,000 patients worldwide. This new QIDP status
expands the eligible ABPA population to include asthmatic patients;
1.5% of adult asthmatics suffer from ABPA.
In its letter to Pulmatrix, the FDA wrote: "We have reviewed
your request and conclude that it meets the criteria for QIDP.
Therefore we are designating your Itraconazole Inhalation Powder
(PUR1900) product for inhalation use as a QIDP for…treatment of
pulmonary Aspergillus infections in patients with allergic
bronchopulmonary aspergillosis (ABPA)."
"This second QIDP designation is a significant boost to our
efforts to make this drug available as quickly as possible to
severe asthma patients suffering from fungal lung infections," said
Pulmatrix CEO Robert Clarke, PhD. "It will give us the benefit of
an expedited regulatory review and significantly expands the
potential population we can treat with our Pulmazole product. This
designation provides Pulmazole with 5 years of market exclusivity
for treatment of fungal lung infections in these patients with
ABPA."
Currently, many asthma patients experience allergic reactions
when their lungs become infected with a fungus called
Aspergillus. Doctors now try to treat those infections with
oral drugs such as corticosteroids and antifungal agents like
itraconazole. Oral antifungals have been shown to provide benefit
in treating ABPA in asthma patients but are limited by
tolerability, safety, and drug-drug interaction concerns based on
the dosing profile. Typically these agents require very high
oral doses to get enough of the drug to the lungs through the
bloodstream to fight the fungus, leading to the safety and
tolerability concerns.
Pulmatrix's goal is to solve this problem by combining
itraconazole with its innovative dry powder iSPERSETM
technology. The combination of iSPERSETM and
itraconazole makes it possible for patients to inhale the drug into
their lungs, to the site of infection, where it's needed while
reducing the amount of drug that gets into the systemic circulation
which drive the safety and tolerability concerns.
"By delivering the drug directly to the lungs, we should be able
to fight the infection far more effectively than the oral drug can,
with far fewer side effects and reduced drug-drug interaction
concerns," explained Pulmatrix's Chief Scientific Officer,
David L. Hava, PhD. "That should
bring great benefits to patients."
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 rare
diseases, including Pulmazole (PUR1900), an inhaled anti-fungal for
patients with severe asthma and cystic fibrosis (CF), and PUR1800,
a narrow spectrum kinase inhibitor for patients with COPD. In
addition, Pulmatrix is pursuing opportunities in major pulmonary
diseases through collaborations, including PUR0200, a branded
generic in clinical development for COPD. Pulmatrix's product
candidates are based on iSPERSE™, its proprietary 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. The Company cautions that such statements
involve risks and uncertainties that may materially affect the
Company's results of operations. 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 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 Securities and Exchange Commission,
including its annual report on Form 10-K filed by the Company with
the Securities and Exchange Commission on March 10, 2017, 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
|
|
Robert Clarke,
CEO
|
William Duke,
CFO
|
(781)
357-2333
|
(781)
357-2333
|
rclarke@pulmatrix.com
|
wduke@pulmatrix.com
|
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SOURCE Pulmatrix, Inc.