Polyphor AG: Polyphor announces successful end of phase II meeting with FDA for Murepavadin in nosocomial pneumonia
EQS Group-News: Polyphor AG / Key word(s): Study results
Allschwil, Switzerland, May 19, 2017, 09:00CET
Polyphor announces successful end of phase II meeting with FDA for Murepavadin in nosocomial pneumonia
The trial design, discussed in several interactions with the FDA, includes a 28-day mortality endpoint and a non-inferiority margin which corresponds to an overall trial size of less than 300 patients. It also includes several measures aimed at ensuring the feasibility of the study.
Giacomo Di Nepi, CEO of Polyphor, said: "We are pleased with the productive interactions and the valuable direction we received from the FDA, and we appreciate the always constructive dialogue had with the FDA over the last months to define the best way to develop a mono-pathogen antibiotic for Pseudomonas aeruginosa and bring it to patients affected by nosocomial pneumonia - a disease with an unacceptable mortality rate of 30-40%".
The Company is working in collaboration with its investigators to finalize the detailed protocol design and taking all the steps for the operational preparation, centers' selection and trial launch, with the objective of starting the overall phase III program in the second half of 2017 and recruiting the first patient by Q1/2018.
About Nosocomial Pneumonia from Pseudomonas Aeruginosa
- Murepavadin (POL7080, in Phase II entering Phase III / Pivotal registration program), a precision Outer Membrane Protein Targeting Antibiotic (OMPTA) against Pseudomonas aeruginosa.
- POL6014 (in Phase Ib), an inhaled inhibitor of neutrophil elastase for the treatment of cystic fibrosis and other severe lung diseases.
- Balixafortide (POL6326, in Phase Ib), an antagonist of the chemokine receptor CXCR4 for combination treatment in oncology.
Polyphor has discovered the OMPTA class and is further developing it, including a broad-spectrum preclinical candidate, to address infections caused by difficult-to-treat, resistant Gram-negative pathogens - one of the most pressing emerging medical needs. The OMPTA represent the first new class of antibiotics against Gram-negative bacteria reaching advanced clinical stage in the last 40 years.
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