SAN DIEGO, June 25 CA-Mpex-Pharmaceutcls
SAN DIEGO, June 25 /PRNewswire/ -- 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(R) 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(R) 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(R)) and other inhaled
antimicrobial agents.
About PARI Pharma and the eFlow(R) Electronic Nebulizer
MP-376 is delivered by a novel inhalation device, the eFlow(R) Electronic
Nebulizer, developed by PARI Pharma GmbH. eFlow(R) 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 efflux-based
resistance to multiple classes of antibiotics.
http://www.mpexpharma.com
SOURCE Mpex Pharmaceuticals, Inc.
