Polyphor granted Clinical Trial Authorisation for inhaled antibiotic
pharmafile | December 22, 2020 | News story | Manufacturing and Production | Polyphor, cystic fibrosis
Polyphor, a Swiss clinical-stage biopharmaceutical company, has announced that the MHRA has granted a Clinical Trial Authorisation (CTA) to begin the first-in-human Phase I study of its novel class antibiotic murepavadin, delivered via the oral inhalation route.
The Phase I study is part of the clinical development plan exploring the inhaled formulation of murepavadin specifically to treat Pseudomonas aeruginosa infections in people with cystic fibrosis (CF), including resistant bacterial strains, and is expected to enrol the first patient in the coming weeks. The company’s clinical development programme was initiated based on the data of the inhaled murepavadin preclinical programme, which suggested significantly higher safety margins compared to the intravenous formulation.
The Phase I study, evaluating safety and tolerability of single and multiple ascending doses of the novel antibiotic in healthy volunteers, is jointly funded by Polyphor and the European Innovative Medicines Initiative (IMI).
A recently granted award from the Cystic Fibrosis Foundation will allow further development until the end of the Phase Ib/IIa study. Inhaled murepavadin is also part of the iABC project, a Europe-wide programme dedicated to the development of inhaled antibiotics run by a consortium of leading lung specialists and research institutions in various European countries.
Infections remain a significant problem for people with CF who require novel treatment options, despite the availability of CFTR modulators. If approved for commercial use, inhaled murepavadin would be the first new class of antibiotics for Gram-negative pathogens in the last 50 years.
Dr Frank Weber, Chief Medical and Development Officer at Polyphor, said: “Patients with CF urgently need new antibiotic options against Pseudomonas aeruginosa infection which is the most important pathogen in progressive and severe CF lung disease.
“Inhaled murepavadin has the potential to address this need and we would like to thank the European Innovative Medicines Initiative and the CF Foundation for their tremendous support and guidance in the development of this innovative programme.”
Darcy Jimenez
Related Content
Vertex announces positive results from trial for cystic fibrosis combination treatment
Vertex Pharmaceuticals has announced positive results from its once-daily vanzacaftor/tezacaftor/deutivacaftor programme, the company’s phase 3 …
Arcturus Therapeutics gains FDA ODD for cystic fibrosis treatment
Arcturus Therapeutics has announced that the US Food and Drug Administration (FDA) has granted Orphan …
Vertex applies to expand indication of cystic fibrosis drug
Vertex has announced that the EMA and MHRA have validated the post marketing applications for …
