Polyphor presents new data at ECCMID on murepavadin and on its novel class of OMPTA antibiotics targeting WHO priority 1 multi-drug resistant pathogens
EQS Group-News: Polyphor AG / Key word(s): Study/Study results
Allschwil, Switzerland, April 24, 2018
Data presented demonstrated that murepavadin displays extremely potent activity on extensively drug resistant (XDR) Pseudomonas aeruginosa in absolute terms and when compared with the standard of care treatment (meropenem) and the recently introduced combination product ceftalozane/ tazobactam[i]. Murepavadin is the most advanced OMPTA and is currently in Phase III clinical trials.
Murepavadin showed potent activity with a MIC90[*] of 0.25 mg/L when tested against a panel of 785 contemporary (2016-2017) XDR Pseudomonas aeruginosa strains for which there are currently limited or no treatment options. The MIC90 for meropenem and ceftalozane / tazobactam were both > 32 mg/L. The results demonstrated that murepavadin is strongly bactericidal, shows a low rate of resistance development and no cross resistance with other antibiotics.
Dr. Glenn Dale, Head of Antibiotic Research and Early Development, Polyphor, commented: "We're pleased to have presented new data on murepavadin at ECCMID showing its activity against XDR strains of Pseudomonas aeruginosa and potential to address a significant unmet need in the treatment of nosocomial pneumonia. We also showed new data on the broader OMPTA class highlighting its potential to target all WHO priority 1 gram-negative pathogens and address serious infections for which there are currently limited treatment options."
Polyphor presented for the first time these data on new medium-spectrum antibiotic compounds from its OMPTA class demonstrating in vitro and in vivo activity towards all Gram-negative WHO priority 1 pathogens - including carbapenem-resistant Enterobacteriaceae (CRE), Acinetobacter and Pseudomonas.
Results demonstrated the OMPTAs show broad and very potent coverage against Gram-negative bacteria, did not show cross-resistance with standard-of-care antibiotics, and also exhibit potent activity against colistin-resistant isolates[ii]. The class, therefore, has a significant potential to provide novel antibiotics against clinically-relevant Gram-negative pathogens.
Polyphor is a clinical stage, privately held Swiss specialty pharma company which has discovered and is developing the OMPTA (Outer Membrane Protein Targeting Antibiotics). The OMPTA are potentially the first new class of antibiotics against Gram-negative bacteria to have reached phase III stage in the last 50 years. The company's lead product, murepavadin, (POL7080) is in Phase III development against Pseudomonas aeruginosa - recognized as a critical priority 1 pathogen by WHO. Polyphor is also developing an immuno-oncology candidate, balixafortide (POL6326), which has achieved clinical proof of concept in a Phase Ib/proof of concept study in combination with eribulin in patients with advanced breast cancer, and a pipeline of further preclinical antibiotics based on its OMPTA platform. Polyphor is based in Allschwil near Basel. For more information, please visit www.polyphor.com.
About Murepavadin (POL7080)
Murepavadin is Polyphor's most advanced product candidate and the first OMPTA in clinical development. It is being developed for the treatment of nosocomial pneumonia (including both hospital-acquired (HABP) and ventilator-associated bacterial pneumonia (VABP)) due to Pseudomonas aeruginosa and has been granted Qualified Infectious Disease Product (QIDP) and fast track designation from the U.S. Food and Drug Administration (FDA) for the treatment of VABP due to Pseudomonas aeruginosa.
Murepavadin is a pathogen specific antibiotic functioning through a novel mechanism of action involving binding to an outer membrane protein of Pseudomonas aeruginosa. In contrast to commonly used broad-spectrum antibiotics, murepavadin is a precision medicine and as such it supports the growing practice known as "antibiotic stewardship" which, among other things, seeks to reduce the excessive use of broad-spectrum products to avoid the buildup of resistance and to preserve the microbiome of the patients. Based on promising Phase II results, Polyphor has agreed on a streamlined development pathway for murepavadin with the FDA and EMA and has started its first Phase III clinical trial.
For further information please contact:
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[*] Minimum inhibitory concentration ("MIC") is a measure of antibacterial activity. MIC90 is the concentration of an antibiotic in which 90% of the isolates growth is inhibited.
[i] Murepavadin activity tested against contemporary (2016-2017) clinical isolates of extensively drug-resistant (XDR) Pseudomonas aeruginosa (#P1661)
[ii] Outer membrane protein targeting antibiotics (OMPTAs): a novel class with potent activity against Gram-negative organisms including XDR and colistin-resistant isolates. Anatol Luther, Ph.D., #O0246
Document: 20180424 Polyphor Press Release ECCMID Data