LEXINGTON, Mass., Jan. 22, 2018 /PRNewswire/ -- Pulmatrix,
Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company
developing innovative inhaled therapies to address serious
pulmonary diseases announced today that it has received
authorization of its Clinical Trial Application from the UK
Medicines and Healthcare Products Regulatory Agency (MHRA) to
initiate its first-in-human study for Pulmazole (PUR1900), an
inhaled iSPERSE™ formulation of the anti-fungal drug
itraconazole for the treatment of allergic bronchopulmonary
aspergillosis (ABPA) in patients with asthma.
ABPA is a disease that occurs most often in patients with
underlying asthma or cystic fibrosis, and it is characterized by an
exaggerated allergic hypersensitivity response of the immune system
to the fungus Aspergillus growing in the airways. Oral itraconazole
(Sporanox®) is currently used as an adjunctive treatment to
corticosteroids in ABPA patients. However, its use is limited by
poor bioavailability, variable pharmacokinetics, and toxicity
concerns related primarily to the risk of gastrointestinal and
cardiac side effects, as well as extensive drug-drug
interactions.
This phase 1/1b study will be
conducted in healthy subjects and patients with mild to moderate
stable asthma. The study will include single ascending dose
(SAD) and multiple ascending dose (MAD) arms in normal healthy
volunteers (NHV) to assess safety, tolerability, and
pharmacokinetics (PK). A third study arm will evaluate safety and
tolerability in patients with mild to moderate stable asthma and
will also include PK analysis of itraconazole levels in the
blood and sputum following administration of a single dose of oral
itraconazole (Sporanox; 200 mg itraconazole) or Pulmazole (20 mg
itraconazole) in a crossover study design. This program represents
the first inhaled dry-powder formulation of itraconazole that the
Company is aware of to enter clinical development.
"We have begun to screen subjects and look forward to initiating
dosing in our first clinical trial for Pulmazole in early
February," commented James Roach,
M.D., Chief Medical Officer of Pulmatrix. "There is a significant
unmet medical need in patients with both asthma and ABPA, and we
believe that by delivering higher doses of itraconazole directly to
the lungs while minimizing systemic exposure, Pulmazole has the
potential to provide significant advantages in both efficacy and
safety relative to oral itraconazole."
The study is planned to include up to 42 subjects in the SAD/MAD
evaluation in NHV and 16 asthmatics in the crossover study. The
company expects that top line results will be available in
mid-2018.
Robert Clarke, Ph.D., Chief
Executive Officer of Pulmatrix, added "The approval to initiate
clinical dosing of Pulmazole is an important step for Pulmatrix in
2018. We expect an ambitious year advancing development of both
Pulmazole and PUR1800 as part of our core company strategy, while
continuing progress on our US partnership of the PUR0200 once daily
bronchodilator program with Vectura."
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
(PUR1900), an inhaled anti-fungal for patients with ABPA, and
PUR1800, a narrow spectrum kinase inhibitor for patients with
obstructive lung diseases including asthma and COPD. In addition,
Pulmatrix has partnered with Vectura Group plc to develop
Pulmatrix's drug candidate, PUR0200, for COPD for the U.S. market.
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.
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.