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Mpex Initiates a
Phase 2 Clinical Trial of Aerosol MP-376 in the
Treatment of Chronic Bacterial Infections in
Cystic Fibrosis Patients
Mpex Pharmaceuticals, Inc. today announced that
it has initiated a Phase 2 clinical study with
MP-376 for the treatment of pulmonary infections
due to Pseudomonas aeruginosa and other bacteria
in patients with cystic fibrosis. MP-376 is
Mpex's proprietary aerosol formulation of
levofloxacin, an antibiotic that has potent
activity against key bacterial pathogens,
including Pseudomonas aeruginosa. Delivery of
levofloxacin directly to the lungs of CF
patients by the aerosol route can potentially
provide a number of safety and efficacy
advantages compared to oral or IV
administration. MP-376 is delivered using a
customized configuration of PARI's highly
efficient eFlow® electronic nebulizer.
"Based on the preclinical and early clinical
work to date, we believe MP-376 has the
potential to be an important new treatment
option for CF patients," stated Dr. Jeffery
Loutit, Chief Medical Officer of Mpex
Pharmaceuticals, Inc. "This study, if
successful, should allow us to select the
appropriate dose and dose schedule for our
pivotal Phase 3 studies, which we hope to
initiate in 2009."
Patients with cystic fibrosis (CF) suffer from
chronic infections of the lower respiratory
tract that can be caused by multiple bacteria,
including Pseudomonas aeruginosa. Chronic
pulmonary infection is associated with a
decrease in lung function over time from
inflammation triggered by bacteria and their
toxins. Periodic exacerbations in the lung
result from bacterial overgrowth, and may
require administration of systemic antibiotics.
Chronic pulmonary infections and associated
exacerbations are implicated as a major cause of
morbidity and mortality in CF patients. The
Phase 2, multi-center, international randomized,
double-blind, placebo-controlled study (Mpex
204) is expected to enroll 140 stable CF
patients to evaluate the safety, tolerability
and efficacy of three dosage regimens of MP-376
given once or twice daily for 28 days. The doses
of MP-376 to be used in this study are based on
clinical and microbiological data from a
previously completed Phase 1b study in which CF
patients received 14 days of varying doses of
MP-376. Data from that study indicated that all
doses were well tolerated and that patients
experienced a reduction in bacterial counts of
Pseudomonas aeruginosa in sputum.
The primary efficacy endpoint to be assessed in
the Phase 2 study will be microbiological
(change in bacterial counts of Pseudomonas
aeruginosa in sputum) over 28 days of dosing.
Additional endpoints and exploratory analyses
will include the time to need for other inhaled
or systemic antibiotics, changes in forced
expiratory volume in one second (FEV1), and
patient-reported outcomes.
About MP-376
MP-376 is a proprietary formulation of
levofloxacin that has been optimized for aerosol
delivery using a customized configuration of
PARI's highly efficient eFlow® electronic
nebulizer. Levofloxacin is a fluoroquinolone
antibiotic that has been widely used in a
variety of indications for over a decade and has
established safety and efficacy when
administered orally or intravenously against
many bacterial pathogens, including Pseudomonas
aeruginosa. Administration of MP-376 with a high
efficiency nebulizer to the lungs allows for the
delivery of high concentrations of active drug
directly to the site of infection, while
minimizing systemic exposure. Mpex believes this
approach has the potential to improve bacterial
killing and reduce resistance development versus
traditional oral or IV routes of administration.
Preclinical and early clinical studies show that
aerosol doses of MP-376 appear to be safe and
well tolerated, and exert an antimicrobial
effect when administered once or twice daily.
High concentrations of levofloxacin in the lung
delivered using MP-376 are expected to be active
against CF pathogens, including those resistant
to aminoglycosides (e.g., TOBI®) and other
inhaled antimicrobial agents.
About PARI Pharma and the eFlow®
Electronic Nebulizer
MP-376 is delivered by a novel inhalation
device, the eFlow® Electronic Nebulizer,
developed by PARI Pharma GmbH. eFlow® is a quiet
portable nebulizer that enables efficient
aerosolization of liquid medications via a
vibrating perforated membrane. Based on PARI's
100-year history working with aerosols, PARI
Pharma is dedicated to advancing inhalation
therapies by developing innovative delivery
platforms and new pharmaceutical formulations
that work together to improve patient care.
About Mpex Pharmaceuticals
Mpex Pharmaceuticals is a clinical stage
biopharmaceutical company whose mission is to
develop important new therapies to combat the
growing issue of antibiotic resistance. The
company's internal development pipeline focuses
on combining proprietary formulations, PK/PD
strategies and novel potentiating agents with
proven antibiotics to overcome or directly
inhibit the molecular mechanisms in bacteria
responsible for antibiotic resistance. Mpex's
most advanced product candidate, MP-376, is a
proprietary aerosol formulation of levofloxacin
that is being developed clinically as a
maintenance therapy for the prevention of
bacterial exacerbations in patients with cystic
fibrosis and severe chronic bronchitis. The
company has also built a discovery and
development platform and intellectual property
estate around inhibitors of multi-drug resistant
(MDR) efflux pumps
(EPIs) found in many gram-negative bacterial
pathogens. Bacterial efflux of antibiotics is a
leading source of multi-drug resistance,
particularly in gram-negative organisms. Mpex
compounds have been shown in both in vitro and
in vivo studies to overcome effluxbased
resistance to multiple classes of antibiotics.
Quick Links...
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www.PARIpharma.com
Contact Information
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Additional information is available by
contacting Kirsten Ayars at 805-452-7909 or
Geoff Hunziker at 831-372-3580. |
