Polyphor reports successful Phase I results for its Pseudomonas selective antibiotic POL7080
Allschwil, Switzerland, March 4, 2013 - Polyphor Ltd today announced the successful completion of a Phase I clinical trial demonstrating the clinical safety and tolerability of its Pseudomonas specific antibiotic POL7080. POL7080 holds great promise for the treatment of bacterial infections caused by multi-drug resistant Pseudomonas bacteria, one of the most clinically relevant pathogens. 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.
About POL7080
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.
About Polyphor Ltd
Polyphor Ltd is a privately held, Swiss, research-driven
pharmaceutical company founded in 1996 dedicated to develop
innovative products with high therapeutic benefit to the patient
and to provide high quality drug discovery support to its
pharmaceutical industry partners. Polyphor has developed a
proprietary macrocycle drug discovery technology platform and
built-up an attractive portfolio of drug candidates thereby
evolving into a clinical stage company.
Its product portfolio includes:
• POL6326, a CXCR4 antagonist, with ongoing and upcoming
Phase II clinical trials for stem cell transplantation, tissue
repair and combination treatments in oncology;
• POL7080, a highly specific antibiotic with a novel mode of
action to treat Pseudomonas infections (Phase I completed);
• POL6014, an inhibitor of neutrophil elastase for the
treatment of Alpha-1 Antitrypsin Deficiency, Cystic Fibrosis, and
other lung diseases by inhalation (ready for IND enabling
studies).
In addition, Polyphor has established R&D collaborations based on its macrocycle technology platform with Novartis and Boehringer Ingelheim.
For additional information, please visit www.polyphor.com
Contact:
Michael Altorfer, Ph.D.
Head Corporate Communications
Polyphor Ltd
t: +41 61 567 16 00
e: PR@polyphor.com
Posted: March 2013
