Polyphor reports successful Phase I results for its antibiotic

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04.03.2013

Polyphor Ltd today announced the successful completion of a Phase I clinical trial demonstrating the clinical safety and tolerability of its antibiotic POL7080 against Pseudomonas bacteria, one of the most clinically relevant pathogens.

The antibiotic of Polyphor – POL7080 - holds great promise for the treatment of bacterial infections caused by multi-drug resistant Pseudomonas bacteria. Some of these bacteria have become resistant to almost all commercially available antibiotics. As POL7080 kills Pseudomonas bacteria by a novel mode of action it can overcome such resistance and therefore has the potential to offer new treatment options for serious and life-threatening infections.
 
All primary study objectives were achieved in this Phase I trial. 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.
 
The study confirmed that this novel antibiotic was well tolerated by healthy volunteers and thus complements the comprehensive safety and tolerability profile of POL7080.
 
Jean-Pierre Obrecht, CEO of Polyphor, commented: “No new class of antibiotics active against Gram-negative bacteria has been approved in several decades. POL7080 is the front runner of a novel class of antibiotics killing Pseudomonas bacteria by a novel mode of action. The positive Phase I data for POL7080 further underscores that our proprietary macrocycle platform can deliver highly innovative drugs that are safe and able to address unmet medical needs. We are proud of this achievement and are dedicated to advance the further development of POL7080, with the objective to bring a new antibiotic to the market and treat patients with life-threatening Pseudomonas infections.”
 
”The safety and pharmacokinetic data obtained in our clinical Phase I trial are very encouraging.  We will advance POL7080 to Phase II trials to demonstrate its efficacy in treating lung infections caused by multi-drug resistant Pseudomonas bacteria, in line with guidance from the health authorities,” added Klaus Dembowsky, Chief Medical Officer.  
 
Polyphor Ltd is a privately held, Swiss, research-driven pharmaceutical company based in Allschwil.

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