LEXINGTON, Mass., May 25, 2016 /PRNewswire/ -- Pulmatrix (NASDAQ:PULM), a specialty pharmaceutical company
developing novel inhaled therapeutic formulations based on the company's proprietary iSPERSE™ technology, has completed a pilot pharmacokinetic study of PUR0200 in
healthy volunteers (HNV). PUR0200 is a dry powder, branded generic of a once-daily of a long-acting muscarinic antagonist (LAMA)
for the maintenance treatment of bronchospasm in patients with chronic obstructive pulmonary disease (COPD). Development of PUR0200 in Europe is
focused on demonstrating bioequivalence between PUR0200 and a currently marketed product.
The completed 7-way crossover design study aimed at defining the relationship of PUR0200 formulation characteristics and the
pharmacokinetic profile of the drug following single doses at each dosing interval to establish formulation parameters for
further development towards formal bioequivalence. The current study builds on pharmacokinetic data collected in a previously
completed Phase 1b study of PUR0200 in moderate-to-severe COPD patients. Data from the Phase 1b study was presented at the
European Respiratory Society meeting in September 2015. Data analysis for the current study is
ongoing.
David Hava, PhD, CSO of Pulmatrix, said: "The completed study should significantly expand on
our understanding of PUR0200 and the reference product pharmacokinetics. We expect to share top line results of the study in the
near future."
Dr Hava added, "Our progress in completing subject recruitment and all clinical procedures is a significant achievement for
Pulmatrix staying on time and budget with our publicly disclosed development plans for PUR0200."
About COPD
COPD is a long term, progressively destructive and life-threatening disease of the lungs. Cigarette smoking is the
most common cause of COPD. Performance of everyday activities may be severely curtailed and overall quality of life significantly
impaired. The most common symptoms of COPD are breathlessness, production of abnormal mucus in the airway, and a chronic cough.
COPD is not curable, but treatment ameliorates symptoms and may slow the progress of the disease. According to the World Health
Organization, approximately 65 million people worldwide had COPD in 2004 and it is predicted to become the third leading cause of
death by 2020.
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 lung diseases, including
opportunities in major pulmonary diseases through collaborations, like PUR0200, a branded generic in clinical development for
chronic obstructive pulmonary disease (COPD) and PUR1900, an inhaled antifungal that could benefit severe asthmatics and patients
with rare disease like cystic fibrosis. 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 annual report on
Form 10-K filed by the Company with the Securities and Exchange Commission on March 10, 2016. 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
(781)
357-2333
rclarke@pulmatrix.com
William Duke, CFO
(781) 357-2333
wduke@pulmatrix.com
Chris Brinzey, Westwicke Partners
(339) 970-2843
IR@pulmatrix.com
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SOURCE Pulmatrix