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
