Allschwil, Switzerland, July 17, 2019
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.
(CH) +41 44 580 6522
(UK) +44 20 3009 2470
(USA) +1 87 7423 0830
For further information please contact:
Chief Financial Officer
Tel: +41 61 567 16 67
Dynamics Group AG
Tel: +41 43 268 32 31
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 in clinical development in the last 50 years against Gram-negative bacteria. The company's lead OMPTA, murepavadin, (POL7080) is in 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 started 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.