Polyphor receives approval to start first-in-human clinical trial of inhaled antibiotic murepavadin

Polyphor AG / Key word(s): Study

22-Dec-2020 / 07:30 CET/CEST
Release of an ad hoc announcement pursuant to Art. 53 KR
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Allschwil, Switzerland, December 22, 2020

Polyphor receives approval to start first-in-human clinical trial of inhaled antibiotic murepavadin

- Phase I safety, tolerability, and pharmacokinetic study in healthy volunteers expected to start in coming weeks following acceptance of a request for a Clinical Trial Authorization (CTA) granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

- Polyphor's inhaled murepavadin is a novel class antibiotic that specifically targets Pseudomonas aeruginosa lung infections in people with cystic fibrosis (CF).

- Phase I development in healthy volunteers is jointly funded by Polyphor and the European Innovative Medicines Initiative (IMI).

Polyphor AG (SIX: POLN) today announced that the UK Medicines and Healthcare products regulatory agency (MHRA) has granted a CTA (Clinical Trial Authorization) to start 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 to treat Pseudomonas aeruginosa infections in people with cystic fibrosis, including resistant bacterial strains. The study is expected to enroll the first patient in the coming weeks. The safety, tolerability, and pharmacokinetic study is using eFlow^(R) Technology nebulizer (PARI Pharma GmbH) to administer murepavadin Inhalation Solution (MIS) in healthy volunteers.

"We are very excited to further expand Polyphor's clinical pipeline with the initiation of this study in a rare disease indication beyond our Phase III immuno-oncology program with balixafortide in advanced metastatic breast cancer. 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", said Dr. Frank Weber, Chief Medical and Development Officer at Polyphor. "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 program."

Polyphor's 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. Based on the data of the inhaled murepavadin preclinical program suggesting significantly higher safety margins (at least 5-10 times) versus the intravenous formulation, Polyphor is initiating a clinical development program in CF. The Phase I study, evaluating safety and tolerability (both overall and local) of single and multiple ascending doses of inhaled murepavadin in healthy volunteers, is jointly funded by Polyphor and the European Innovative Medicines Initiative (IMI). 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 in 2021. 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 program 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. It would also be potentially the first agent to target specifically Pseudomonas aeruginosa bacteria versus the current standard of care, broad spectrum inhaled antibiotics.

For further information please contact:

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Bernhard Schmid
LifeSci Advisors
+41 44 447 12 21
bschmid@lifesciadvisors.com

About Polyphor
Polyphor is a research-driven clinical-stage, Swiss biopharmaceutical company committed to discovering and developing best-in-class molecules in oncology and antimicrobial resistance leveraging the company's leading macrocyclic peptide technology platform. Polyphor is advancing balixafortide (POL6326) in a Phase III trial in combination with eribulin in patients with advanced breast cancer and exploring its potential in other cancer indications. In addition, it has discovered and is developing the Outer Membrane Protein Targeting Antibiotics (OMPTA). 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 program is an inhaled formulation of murepavadin for the treatment of Pseudomonas aeruginosa infections in patients with cystic fibrosis. 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.

Disclaimer
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.