Pulmatrix Taps
Robert Clarke, Ph.D. CEO, Releases Promising Data on Lung Drug
Lexington, MA
– September 4, 2012 – Pulmatrix, a clinical stage biotechnology company
creating novel inhaled therapeutics, today announced the appointment of Robert
Clarke, Ph.D., as Chief Executive Officer. Dr. Clarke takes on the role of CEO
at a time when Pulmatrix is rapidly advancing its proprietary iCALM™ inhaled
drug candidates in human clinical trials for chronic respiratory diseases,
including chronic obstructive pulmonary disease (COPD) and cystic fibrosis.
Under his leadership in his previous role as the Chief Scientific Officer of
Pulmatrix, Dr. Clarke expanded the capabilities of the company’s iSPERSE™
platform to evolve beyond proprietary iCALM therapies to also include delivery
of novel single and combination therapeutics of inhaled dry powder drug
products. Dr. Clarke is a seasoned biopharmaceutical leader with experience
growing early stage research and development programs in pulmonary therapeutics
into clinical development.
"I am
excited to take on this leadership role at Pulmatrix at such a pivotal time, as
we advance our novel platform and therapeutics with breakthrough potential to
address unmet needs of patients with chronic respiratory diseases," said
Robert Clarke, Ph.D., Chief Executive Officer of Pulmatrix. "Pulmatrix has
tremendous potential to develop multiple novel product opportunities from our
iSPERSE platform, including the advancement of our proprietary iCALM therapies
through clinical trials."
As Chief
Executive Officer, Dr. Clarke succeeds Robert Connelly who has left Pulmatrix
to lead a start-up company applying novel science. Mr. Connelly will continue
to serve on the Board of Directors for Pulmatrix. Dr. Clarke has also been
appointed to the company’s Board of Directors.
“Pulmatrix is
on a very promising clinical development path and Bob Clarke is the ideal
choice to lead it through this important stage. We have incredible confidence
in Bob Clarke’s ability to take Pulmatrix to the next level, as his
accomplishments in discovering the novel efficacy of iCALM and expanding the
capabilities of the iSPERSE platform have created a wide range of valuable
product and partnering opportunities for the company,” said Terry McGuire,
board member and partner at Polaris Venture Partners. “We also recognize Bob
Connelly’s significant contribution to building Pulmatrix into a clinical stage
biotech with several very promising drugs in development for chronic
respiratory diseases, and we look forward to his continuing involvement on the
Pulmatrix board.”
Dr. Clarke
was promoted to Chief Executive Officer of Pulmatrix after serving as the
company’s Chief Scientific Officer and Vice President of Research and
Development. Joining Pulmatrix in 2004 as the first Ph.D. level scientist, his
role evolved to oversight of research and development efforts at Pulmatrix
focused on developing the Pulmatrix technologies, iCALM and iSPERSE, for
treatment of respiratory disease. He has helped raise $60 million in venture
capital funding for the company as well as secured $10 million in non-dilutive
funding to support Pulmatrix’s research and development programs. Previous to
Pulmatrix, he was an Associate Director of Life Sciences at Alkermes, Inc.
focused mainly on developing inhaled therapeutic products with the AIR
technology platform. Dr. Clarke holds a B.Sc. in Biomedical Engineering from
Boston University, has his Ph.D. in Physiology from Johns Hopkins University,
and completed his post-doctoral training in Respirator y Biology at Brigham and
Women’s Hospital and Harvard University. Dr. Clarke has over a dozen years
industry experience and over 20 years total experience focused on pulmonary
drug delivery and the role of inhaled particles in respiratory biology and
medicine, leading to co-authorship of over 80 chapters, papers, and abstracts.
Pulmatrix
Presents Top Line Clinical Data Showing Inhaled Drug Candidate, PUR118, Demonstrated
Anti-Inflammatory Efficacy In Phase 1b Trial with COPD Patients
Clinical Results from Lead Product Candidate Created from Pulmatrix’s Proprietary
iSPERSE™ Inhaled Therapeutics Platform
Three
Presentations at European Respiratory Society Highlight Data Related to PUR118
Lexington, MA
– September 4, 2012 – Pulmatrix, Inc., a clinical stage biotechnology company
creating novel inhaled therapeutics, today announced top line results from a
clinical study showing that the novel inhaled therapeutic, PUR118, demonstrated
anti-inflammatory efficacy and was well-tolerated in two Phase 1b studies in
patients with chronic obstructive pulmonary disease (COPD). These results, that
showed PUR118’s beneficial impact on biomarkers of airway inflammation and mucus
clearance, are the first clinical efficacy results from PUR118 which is the
company’s lead iCALM™ inhaled therapeutic candidate created from the iSPERSE™
dry powder delivery platform. Design aspects of these clinical trials, along
with supporting and related preclinical data, were presented at the European
Respiratory Society (ERS) Annual Congress on Monday, September 3, 2012, in
Vienna, Austria.
“These
clinical data clearly validate the potential for PUR118 to control COPD
patients’ symptoms and significantly improve their lung function, while also
showing PUR118 to be well tolerated,” said John Hanrahan, MD, MPH, Chief
Medical Officer and Senior Vice President at Pulmatrix. “Based on the strength
of these initial efficacy signals, we intend to now move forward into a Phase 2
trial of PUR118 in COPD patients, accelerating this clinical program with a
goal of more rapidly bringing this unique treatment approach to patients with
inflammatory airway conditions and the physicians who care for them.”
The
presentations at ERS highlight PUR118’s potential to offer a new inhaled
approach for control of airway inflammation in COPD and other respiratory conditions.
PUR118 clinical and preclinical data highlights include:
• A Phase 1b
clinical trial that showed PUR118 was well tolerated in both healthy volunteers
and patients with COPD;
• Exploratory
endpoints in the Phase 1b clinical study that assess biomarkers of inflammation
and mucus clearance support a favorable impact of PUR118 treatment on both
airway inflammation and mucociliary airway clearance velocity;
• Phase 1b
clinical data demonstrated reduction in the levels of the same critical airway
inflammatory signaling molecules/biomarkers evident in preclinical models, and
confirmed preclinical data on the ability of PUR118 and iCALM therapies to
reduce airway neutrophilic inflammation, as reported in previous studies and
those presented at ERS;
Preclinical
data from PUR118 and related iCALM studies presented at ERS demonstrated robust
and consistent airway anti-inflammatory impact in animal models of a number of
chronic diseases. Highlights from these preclinical studies included: PUR118
reduced tobacco smoke induced chemokine and cytokine protein levels associated
with neutrophilic inflammation in mouse BAL samples, suggesting that its
anti-inflammatory efficacy is comparable to other clinical stage targets (p38 /
PDE4) with demonstrated clinical efficacy; PUR118 reduces TLR-induced chemokine
and cytokine secretion and gene expression in macrophages, suggesting that the
in vivo activity of PUR118 and other iCALM therapeutics is at least partially
mediated through activity on macrophages.
• PUR118 was clinically
evaluated in an innovative Phase 1 clinical study, and the design and
implementation of the Phase 1 study were jointly presented by Pulmatrix and
Quotient Clinical in a poster at ERS.
About the
Phase 1 Trial Design for PUR118
The clinical
development program for PUR118 comprises a Phase 1 trial structured into a
four-part, dose-ranging clinical study protocol, first in healthy normal
volunteers and then patients with COPD. Part 1 of this clinical study was a
randomized, placebo controlled, single ascending dose, 4-way crossover
tolerability/safety study in 12 healthy male and female subjects aged 18 to 65.
Part 2 was a randomized, double-blind (2 active, 1 placebo),
placebo-controlled, multiple-dose group, 14 day dose escalation design in 24 healthy
male and female subjects age 18 to 65. Part 3 was an open-label, parallel group
design in 36 male and female subjects aged 45 to 70 years, with mild (GOLD
stage 1-2), stable COPD. Part 4 was an open-label, single dose, 4 way crossover
design in male and female ex-smoking subjects age 45-70, with mild (GOLD stage
0-2), stable COPD. In each part of this four-part Phase 1 trial, tolerability
and safety of PUR118 was assessed at each dose level. Additionally, the effect
of PUR118 on mucociliary airway clearance velocity over the 2 hours after
dosing was evaluated along with exploratory and relevant biomarkers for
efficacy.
About PUR118
PUR118 is the
lead iCALM product candidate from Pulmatrix’s proprietary iSPERSE dry powder
delivery platform. PUR118’s novel mechanism of action as an iCALM therapeutic
is designed to harness the body’s natural defenses to prevent and treat chronic
respiratory diseases and respiratory infections in diseases such as chronic
obstructive pulmonary disease (COPD) and cystic fibrosis. Clinical and
preclinical data with PUR118 have demonstrated the ability to treat and prevent
disease, in both viral and bacterial diseases, as well as reduced inflammation
in the lung. PUR118 is in human clinical efficacy studies for COPD and cystic fibrosis.
About
Pulmatrix
Pulmatrix,
Inc. is a clinical stage biotechnology company developing and commercializing a
novel inhaled dry powder drug platform to create a new generation of inhaled
therapeutics. The platform, called iSPERSE™ (inhaled small particles easily
respirable and emitted), enables drugs to be delivered in inhaled dry powders
with unique properties for high drug loading and highly efficient
dispersibility and delivery to the airways. iSPERSE can create dry powder
formulations with virtually any drug substance, including small molecules,
biologics and multi-drug combinations, as well as the company’s proprietary
iCALM™ (inhaled Cationic Airway Lining Modulators) inhaled therapies. The
Company is pursuing both proprietary and partnered applications for iCALM and
iSPERSE. For additional information about Pulmatrix, please visit http://www.pulmatrix.com
ICALM™ and
iSPERSE™ are trademarks of Pulmatrix, Inc.
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