Mpex Initiates Phase 3 Clinical Trial Program with Aeroquin™ for the Treatment of Chronic Bacterial Infections in Cystic Fibrosis Patients

SAN FRANCISCO, Jan. 10, 2011 /PRNewswire/ -- Mpex Pharmaceuticals, Inc. today during the JP Morgan 29th Annual Healthcare Conference, announced that it has initiated its Phase 3 clinical trial program with Aeroquin™ (MP-376) for the treatment of pulmonary infections in patients with cystic fibrosis (CF). Aeroquin is Mpex's proprietary aerosol formulation of levofloxacin, an antibiotic that has potent activity against key bacterial pathogens in CF including Pseudomonas aeruginosa.

The first study in this program is a multi-center, international, randomized, double-blind, placebo-controlled trial (Mpex 207) that is expected to enroll approximately 300 stable CF patients to evaluate the safety, tolerability and efficacy of 240 mg of Aeroquin administered twice daily using an optimized, Investigational eFlow Nebulizer System for 28 days. To ensure that results from this trial are predictive of efficacy in heavily treated cystic fibrosis patient and consistent with current clinical practice, the study will enroll patients that have recently received multiple courses of inhaled antibiotics and in most cases are receiving concomitant medication such as dornase alpha, azithromycin and hypertonic saline.  Patient enrollment in this study has already begun.

The primary efficacy endpoint to be assessed in the trial will be time to exacerbation. Additional endpoints include time to need for anti-pseudomonal antimicrobials, as well as change from baseline to Day 28 in lung function, the respiratory domain score of the CFQ-R and sputum Pseudomonas aeruginosa density.

An additional Phase 3 trial comparing Aeroquin to TOBI® (tobramycin inhalation solution) over three 28-day cycles (Mpex 209) is expected to begin enrolling patients in the next several weeks.

A previous Phase 2b study in 151 CF patients (Mpex 204) demonstrated that Aeroquin had a significant impact on bacterial load, respiratory function and time to need for anti-pseudomonal antibiotics (a measure of exacerbations) versus placebo in a heavily treated patient population. The primary endpoint, a reduction in sputum Pseudomonas aeruginosa density at Day 28 (end of treatment) was achieved, with a twice daily 240mg dose showing the greatest effect. Statistically significant improvements in respiratory function including percent predicted FEV1, FEF25-75 and percent predicted FVC at Day 28 versus placebo were also observed with the 240mg twice-daily dose. Consistent with these results, a statistically significant reduction in the need for other inhaled and/or systemic anti-pseudomonal antimicrobials was also observed.  There were no safety concerns identified in Mpex 204 and there was no evidence for emergence of bacterial resistance during the study.

"The Phase 2b study with Aeroquin showed strong, consistent results in a very heavily treated patient population which bodes well for Phase 3," stated Jeff Loutit, Chief Medical Officer of Mpex Pharmaceuticals, Inc.  "A new inhaled antimicrobial with potent activity against a broad spectrum of pathogens, good tolerability, and with a low treatment burden would be a significant advance for CF patients.  We are very excited to be starting this Phase 3 program and look forward to working with patients and clinical investigators to extend the results we observed in our Phase 2b trial."

Results from the Aeroquin Phase 3 program are expected in mid-2012.  

About Cystic Fibrosis

Patients with 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 caused by inflammation arising from bacteria and their toxins. Periodic exacerbations in the lung result from bacterial overgrowth (requiring antibacterial intervention), and these exacerbations are implicated as a major cause of morbidity and mortality in CF patients.

About Aeroquin (MP-376)

Aeroquin is a proprietary formulation of levofloxacin that has been optimized for aerosol delivery using an optimized Investigational eFlow Nebulizer System (PARI Pharma GmbH). 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 Aeroquin with a high efficiency nebulizer to the lungs allows for the delivery of high concentrations of active drug directly to the site of infection in approximately 5 minutes, while minimizing systemic exposure.

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. Mpex's most advanced product candidate, Aeroquin™ (MP-376), is a proprietary aerosol formulation of levofloxacin that is being developed clinically as a therapy for patients with cystic fibrosis. The Company has a number of additional antibiotic programs designed to address antibiotic resistance in gram negative organisms, including a collaboration with GlaxoSmithKline focused on developing multiple drug candidates utilizing Mpex's efflux pump inhibitor (EPI) technology. Company website: www.mpexpharma.com.

About the Investigational eFlow Nebulizer System and PARI Pharma

Aeroquin (MP-376) is delivered via an Investigational eFlow Nebulizer System, an inhalation delivery device optimized specifically for Aeroquin. The Investigational eFlow Nebulizer System uses eFlow® Technology to enable highly efficient aerosolization of medication via a vibrating, perforated membrane that includes thousands of small holes to produce the aerosol mist. Compared to other nebulization technologies, eFlow Technology produces aerosols with a very high density of active drug, a precisely defined droplet size, and a high proportion of respirable droplets delivered in the shortest possible period of time. Combined with its quiet mode of operation, small size (it fits in the palm of the patient's hand), light weight and battery use, eFlow Technology reduces the burden of taking daily, inhaled treatments. PARI Pharma focuses on the development of aerosol delivery devices and comprehensive inhalation drug development to advance aerosol therapies where drug and device can be optimized together.

SOURCE Mpex Pharmaceuticals, Inc.