LEXINGTON, Mass., June 13, 2018 /PRNewswire/ -- Pulmatrix,
Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company
developing innovative inhaled therapies to address serious
pulmonary diseases announced today the publication of data from a
dose-ranging Phase 1 clinical study of PUR0200 in COPD patients.
PUR0200 is a once-daily, reformulation of tiotropium bromide for
COPD patients and is being developed as a branded alternative to
Spiriva® HandiHaler®. The data was
published online in the British Journal of Clinical
Pharmacology.
PUR0200 combines tiotropium bromide, the active component in
the billion-dollar blockbuster drug Spiriva, with Pulmatrix's
innovative iSPERSE™ drug delivery platform.
iSPERSE utilizes salt based excipients and spray-drying to create
particles for inhalation that are intended to improve the delivery
of drugs to the lungs compared to lactose-blend dry powders. In the
published study, moderate-to-severe COPD patients were administered
one of three PUR0200 doses (3mg, 6mg or 9mg tiotropium bromide),
Spiriva HandiHaler (18mg tiotropium bromide) or placebo in a 5
period cross-over study design. PUR0200 treatment at all doses
resulted in a statistically significant increase in FEV1 compared
to placebo and caused similar bronchodilation compared to Spiriva
HandiHaler. The lowest PUR0200 dose achieved a similar clinical
effect to Spiriva HandiHaler at a dose that was 83% lower and
resulted in >30% less plasma drug exposure. The
PUR0200 dose was generally safe and well tolerated at all doses
compared to Spiriva HandiHaler.
"The results from this Phase 1 clinical study of PUR0200 are the
first clinical demonstration of the delivery advantages of the
Pulmatrix iSPERSE technology compared to lactose-based dry powder
inhalers," said David Hava,
Ph.D., Chief Scientific Officer for Pulmatrix. "The
ability to achieve similar lung deposition and clinical improvement
at reduced exposure to patients highlights the potential of iSPERSE
to enable differentiated versions of existing products and to
enable new products for the treatment of respiratory disease."
"Tiotropium is a widely prescribed bronchodilator used in the
management of COPD, often delivered as a dry powder using Spiriva
HandiHaler," said Dave Singh, MD,
Professor of Clinical Pharmacology and Respiratory Medicine at the
University of Manchester,
principle investigator on the study and lead author on the paper.
"The clinical data published in the British Journal of Clinical
Pharmacology highlight the delivery advantages of PUR0200 and the
potential to achieve clinically meaningful improvements in
pulmonary function at reduced doses. In the future, the iSPERSE
technology has the potential to enable new formulations of
bronchodilators or novel drugs for the treatment of COPD."
In September of last year, Pulmatrix announced that it has
partnered with Vectura Group plc (LSE: VEC) ("Vectura") to
develop PUR0200 for the U.S. market. Vectura intends to
utilize its innovative dry power inhaler device technology to
deliver PUR0200, with the goal of providing enhanced delivery and a
better device format of PUR0200 for patients.
Link to the abstract for the manuscript:
https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bcp.13645
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"). 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 13, 2018, 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.