Allschwil, Switzerland, April 16, 2019
Polyphor announces enrollment of first patient in PRISM-UDR - the second, FDA agreed - Phase III clinical trial for murepavadin in patients with nosocomial pneumonia
Murepavadin is the lead, pathogen specific, Phase III antibiotic belonging to the OMPTA family and potentially the first drug of a new class of antibiotics against Gram-negative bacteria in more than 50 years
Polyphor today announced the enrollment of the first patient in its PRISM-UDR clinical trial, the second Phase III study for murepavadin (POL7080) for the treatment of hospital-acquired (HABP) and ventilator-associated bacterial pneumonia (VABP) due to Pseudomonas aeruginosa. Murepavadin is also being evaluated in the ongoing PRISM-MDR Phase III trial in patients with nosocomial pneumonia, which started in March 2018.
PRISM-UDR is a global Phase III multicenter, sponsor blinded, randomized, active-controlled, parallel-group, non-inferiority study of murepavadin combined with ertapenem in adult patients with nosocomial pneumonia due to Pseudomonas aeruginosa. The primary efficacy objective is to demonstrate non-inferiority (20% non-inferiority margin) of murepavadin compared to an anti-pseudomonal β-lactam-based antibiotic. The study was designed based on feedback from the U.S. Food and Drug Administration (FDA) and is agreed as the basis for a potential approval in the US. Eligible subjects with a high probability of nosocomial pneumonia due to Pseudomonas aeruginosa will be allocated at random to receive murepavadin or a comparator beta-lactam agent in a 1:1 ratio. The primary analysis population will comprise 210 subjects (105 subjects per arm) with nosocomial pneumonia confirmed to be due to Pseudomonas aeruginosa.
"The initiation of the PRISM-UDR clinical trial demonstrates our continued commitment to bringing forward this potential new treatment option for patients with nosocomial pneumonia due to Pseudomonas aeruginosa," commented Frank Weber, Polyphor Director and a.i. Chief Medical and Development Officer. "New therapeutic options are desperately needed, and we look forward to future clinical development milestones for murepavadin."
For more information about the PRISM-UDR clinical trial of murepavadin, please visit www.clinicaltrials.gov (Identifier: NCT03582007)
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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 Phase III clinical program.
Polyphor is a clinical stage, Swiss biopharmaceutical company focused on the discovery and development of antibiotics and immuno-oncology compounds. It 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 OMPTA, murepavadin, (POL7080) is in Phase III development against Pseudomonas aeruginosa - recognized as a critical priority 1 pathogen by WHO; in addition, Polyphor is developing a pipeline of further preclinical antibiotics based on its OMPTA platform. In addition, Polyphor is developing an immuno-oncology candidate, balixafortide (POL6326), which is starting a Phase III trial in combination with eribulin in patients with advanced breast cancer, and exploring in parallel its potential for further combinations and indications. Polyphor is based in Allschwil near Basel and is listed on the SIX Swiss Exchange (SIX: POLN). For more information, please visit www.polyphor.com.
This press release contains forward-looking statements which are based on current assumptions and forecasts of the Polyphor management. Known and unknown risks, uncertainties, and other factors could lead to material differences between the forward-looking statements made here and the actual development, in particular Polyphor's results, financial situation, and performance. Readers are cautioned not to put undue reliance on forward-looking statements, which speak only of the date of this communication. Polyphor disclaims any intention or obligation to update and revise any forward-looking statements, whether as a result of new information, future events or otherwise.