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Polyphor and EnBiotix announce dosing of first patient in a first-in-human clinical trial of inhaled murepavadin

Ad hoc announcement pursuant to Art. 53 LR

Allschwil, Switzerland, December 15, 2021

Polyphor and EnBiotix announce dosing of first patient in a first-in-human clinical trial of inhaled murepavadin

Polyphor AG (SIX: POLN) and EnBiotix Inc. today announced that the first subjects have been dosed in the first-in-human Phase I trial of a novel-class antibiotic murepavadin, delivered via the oral inhalation route. The current Phase I study to administer murepavadin Inhalation Solution (MIS) using an eFlow(R) Technology nebulizer (PARI Pharma GmbH) will investigate the safety, tolerability, and pharmacokinetics of murepavadin in healthy volunteers. The Phase I trial is part of the clinical development plan exploring the inhaled formulation of murepavadin to treat Pseudomonas aeruginosa infections in people with cystic fibrosis (CF), including resistant bacterial strains.

Following the completion of the asset purchase agreement, by which EnBiotix acquired the assets related to inhaled murepavadin, Polyphor continues to sponsor the Phase I trial on behalf of EnBiotix.

“We are very excited about the start of this important trial with inhaled murepavadin in a rare pulmonary disease indication. Even with the advent of CFTR corrector therapy, CF patients with chronic Pseudomonas aeruginosa infection still urgently need new antibiotic options and inhaled murepavadin has the potential to provide a significant advancement in the treatment of these patients”, said Jeffrey Wager, M.D., Chairman and Chief Executive Officer of EnBiotix. “As we progress to complete the planned merger with Polyphor this year, we ensure timely continuation of our programs, and we are grateful to the European Innovative Medicines Initiative (IMI) for their tremendous support and guidance.”

Infections remain a significant problem for people with CF who require novel treatment options, despite the availability of CFTR modulators. Inhaled murepavadin is currently being developed as a precision antibiotic specifically for the treatment of chronic Pseudomonas aeruginosa infections in people with CF. It is the first member of the Outer Membrane Protein Targeting Antibiotics (OMPTA), a novel class of antibiotics which was discovered by Polyphor and the University of Zurich and displays a unique mode of action. The Phase I trial of inhaled murepavadin in healthy volunteers is jointly funded by Polyphor and the European Innovative Medicines Initiative (IMI). Inhaled murepavadin is part of the iABC project, a Europe-wide program dedicated to the development of inhaled antibiotics run by a consortium of leading lung specialists and research institutions in various European countries. A Phase Ib/IIa trial in adults with CF, assessing safety and tolerability of ascending doses of inhaled murepavadin, is planned to be initiated following completion of the Phase I study. The granted award from the Cystic Fibrosis Foundation is expected to allow further development until the end of the Phase Ib/IIa study.

Full PR available here