Polyphor temporarily halts enrollment in the Phase III studies of murepavadin for the treatment of patients with nosocomial pneumonia
Polyphor AG / Key word(s): Study
Allschwil, Switzerland, May 9, 2019
"While pro-actively halting the Phase III trials for murepavadin is disappointing, patient safety is of utmost importance to Polyphor," said Frank Weber, Polyphor Director and Chief Medical and Development Officer a.i. "We are trying to better understand the reasons for these events and exploring ideas on how to tackle them for the future, as we remain convinced that murepavadin could still represent a valuable drug to help patients fighting pseudomonas infections."
The decision to temporarily halt enrollment applies only to the PRISM-MDR and PRISM-UDR studies and does neither impact the further development of the murepavadin inhaled program, nor the advancement of the OMPTA program, nor the development of the immuno-oncology candidate, balixafortide (POL6326), which is starting a Phase III trial in combination with eribulin in patients with advanced metastatic breast cancer.
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About the PRISM-MDR study
The study was designed based on feedback from the European Medicines Agency (EMA) and is agreed as the basis for a potential approval in the EU. The primary efficacy objective of the study is to assess the clinical cure rate at TOC in the mITT population. Eligible subjects with a high probability of VABP due to Pseudomonas aeruginosa will be randomized in a 2:1 ratio. The miTT population shall comprise 120 evaluable subjects (80 in the treatment arm) with VABP confirmed to be due to Pseudomonas aeruginosa.
About the PRISM-UDR study
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