Polyphor closes the Phase III PRISM studies of murepavadin intravenous formulation and evaluates further product improvement options
Polyphor today announced that it has decided to close the Phase III PRISM MDR and UDR studies of murapavadin intravenous (i.v.) for hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) which have been put on a voluntary temporary hold on May 9th, 2019.
The findings of a rise of creatinine concentration in the serum of patients indicating a higher than expected frequency of acute kidney injury have been confirmed by the analysis of all patients in the murepavadin arm of the PRISM MDR study. There was no increase in the incidence of mortality in the murepavadin arm compared to the control arm - the 28 days mortality rates were 30.0% in the murepavadin arm and 37.5% in the control arm.
In parallel, Polyphor has identified a number of options and activities - some of which have already started - to potentially improve the benefit risk ratio of the intravenous formulation of murepavadin for the treatment of HABP/VABP - and will evaluate these options in the next months.
The decision to stop the PRISM trials applies only to the intravenous murepavadin formulation and does neither impact the further development of the murepavadin inhaled program nor the advancement of the OMPTA program.
The development of Polyphor's immuno-oncology candidate, balixafortide (POL6326) continues as planned with full commitment. Polyphor started in the last quarter the FORTRESS Phase III trial of balixafortide in combination with eribulin in patients with advanced metastatic breast cancer.
"We would like to thank the patients, the investigators and all the scientists involved for their contribution to the development of murepavadin i.v. in HABP/VABP, and look forward to evaluating the options for its improvement. In addition, we remain fully committed to the development of our other Phase III compound, balixafortide, as well as of murepavadin inhaled and our OMPTA platform," said Giacomo Di Nepi, Polyphor CEO.
An update on the whole development program will be given with the publication of the half year results on September 4, 2019. Polyphor will host today a conference call for investors at 17:00 CET for immediate questions. Giacomo Di Nepi, CEO and Frank Weber, CMDO a.i. will be available for a Q&A session.
- Kalina Scott