Thursday, May 9, 2019 @ 6:00 pm
Polyphor (SIX: POLN) today announced the decision to temporarily halt enrollment for the pivotal Phase III trials PRISM-MDR and PRISM-UDR evaluating murepavadin in patients with nosocomial pneumonia due to higher than expected acute kidney injury incidences in the murepavadin arm of the PRISM-MDR trial. The kidney alteration incidences were observed in 56% of the patients treated in the PRISM-MDR study. According to literature and the comparator arm, an estimated incidence of 25-40% was expected. The decision has been taken consensually with the independent Data Monitoring Committee. An update on the continuation of both Phase III studies will be provided in July once all data will be available and reviewed.
"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.