Mpex Pharmaceuticals Initiates Multi-Dose Clinical Trial In The U.S. With MP-376 In Patients With Cystic Fibrosis

Main Category: Cystic Fibrosis
Also Included In: Respiratory / Asthma;  Infectious Diseases / Bacteria / Viruses;  Clinical Trials / Drug Trials
Article Date: 19 Jul 2007 - 0:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Mpex Pharmaceuticals, Inc. today announced the initiation of a Phase 1b clinical trial with its lead compound, MP-376, in patients with cystic fibrosis (CF). MP-376 is a proprietary aerosolized formulation of the antibiotic levofloxacin that is being developed for the treatment of chronic lung infections due to Pseudomonas aeruginosa in CF patients. Preclinical and early clinical studies indicate that active levofloxacin concentrations in pulmonary tissues after MP-376 administration are markedly increased compared to those achieved when the antibiotic is delivered by other routes of administration. The trial is being conducted under an open Investigational New Drug Application (IND) that has been filed with the U.S. Food and Drug Administration (FDA).

MP-376 employs a number of formulation enhancements and has been designed for use in conjunction with a high efficiency nebulizer to rapidly deliver high pulmonary concentrations of levofloxacin to the lung. Compared to other treatment options, regimens of MP-376 are projected to have powerful activity against key bacterial pathogens resident in the CF lung and provide exposures that reduce the selection of bacterial resistance.

The current clinical trial is a randomized, placebo-controlled, multi-center study in the U.S. that will evaluate the safety, tolerability, pharmacokinetics, and microbiological effects of multiple daily doses of MP-376 in stable cystic fibrosis patients with chronic infections due to Pseudomonas aeruginosa. A total of 39 patients are planned to be enrolled, and several dose levels will be evaluated.

This study complements a single dose, dose escalation study of MP-376 that was recently completed in healthy volunteers and CF patients in Denmark. Together, the single and multiple dose trials are expected to support a larger Phase 2 study that the company plans to initiate in 2008.

"We are collaborating with numerous CF physicians who are enthusiastic about the potential for MP-376 in treating difficult chronic lung infections," stated Dr. Michael Dudley, Senior Vice President of Research and Development for Mpex. "Based on our work to date, we believe MP-376 has the potential to provide doctors and patients with a convenient, powerful and well-tolerated new treatment option that addresses key pathogens in CF and minimizes the potential for drug resistance. We look forward to working with the CF community to rapidly advance MP-376 through clinical development."

About Mpex Pharmaceuticals:

Mpex Pharmaceuticals is a clinical stage biopharmaceutical company whose mission is to develop critical new therapies to combat the growing issue of antibiotic resistance. The company's initial focus is on the treatment of gram-negative bacterial pathogens such as Pseudomonas aeruginosa, for which limited effective treatment options exist. Mpex's lead product candidate, MP-376, is currently in Phase 1b clinical trials and is being developed for the treatment of chronic lung infections due to Pseudomonas aeruginosa in cystic fibrosis patients. The company is also pursuing applications related to its extensive intellectual property estate around inhibitors of bacterial multi-drug resistant (MDR) efflux pumps (EPIs). Efflux pumps have been shown to be a primary source of drug resistance in gram-negative organisms. Mpex has identified a number of promising lead EPI compounds that, when combined with existing antibiotics, have been shown to restore the potency of these existing antibiotics against previously resistant gram-negative organisms. These compounds are being profiled in further preclinical studies and may be candidates for clinical development. Additional information about Mpex can be obtained from the company's website at http://www.mpexpharma.com.

Mpex Pharmaceuticals, Inc.
http://www.mpexpharma.com