Polyphor developed the antibiotic Murepavadin for the treatment of the drug-resistant bacteria Pseudomonas aeruginosa, which is responsible for common hospital-acquired infections.
Polyphor has now announced that it has held a successful end of phase II clinical meeting with the US Food and Drug Administration (FDA), in which they discussed further development of Polyphor’s leading product candidate. Polyphor is now planning a Phase III programme for the second half of 2017 and will begin recruiting the first patients in the beginning of 2018.
The successful meeting also means that Polyphor has now met the requirements to release the next tranche of financing. Polyphor successfully concluded a financing round in April in which it secured more than USD 40 million, much of which came from existing investors. The release of USD 30 million of this was contingent on a successful meeting with the FDA.
“We are pleased with the productive interactions and the valuable direction we received from the FDA,” said Polyphor CEO Giacomo Di Nepi. The dialogue with the FDA focused on defining “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 per cent,” he added.