Date: 2013-03-04
Type of information: Initiation of preclinical development
phase: 1
Announcement: results
Company: Polyphor (Switzerland)
Product: POL7080 (murepavadin)
Action
mechanism: POL7080 is a synthetic cyclo-peptide arising from Polyphor’s proprietary Protein Epitope Mimetics (PEM) Technology with potent and selective antimicrobial activity against Pseudomonas bacteria. It has a novel mode of action which is different from all other known antibiotics. POL7080 targets the ß-barrel protein LptD (Imp/OstA), which is involved in the outer-membrane biogenesis of LPS (Srinivas et al 2010, Science 327: 1010 – 1012). In preclinical studies the compound was highly active on a broad panel of clinical isolates including multi-drug resistant Pseudomonas bacteria demonstrating outstanding in vivo efficacy in septicemia, peritonitis, lung and thigh infection models.
Disease: infections caused by multi-drug resistant Pseudomonas
Therapeutic area: Infectious diseases
Country: Europe
Trial
details: The study was a randomised, double-blind, placebo-controlled Phase I dose escalation trial assessing the safety, tolerability, and pharmacokinetics of POL7080 in 52 healthy male volunteers. Thirteen cohorts received intravenous single ascending doses or multiple ascending doses over a period of 6 days. POL7080 was applied as 2 and 3 hours infusions from once daily to three times daily with doses of up to 10 mg/kg/day.
Latest
news: * On March 4, 2013, Polyphor has announced the successful completion of a Phase I clinical trial demonstrating the clinical safety and tolerability of its Pseudomonas specific antibiotic POL7080. All primary study objectives were achieved in this Phase I trial. The study confirmed that this novel antibiotic was well tolerated by healthy volunteers and thus complements the comprehensive safety and tolerability profile of POL7080.
