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

 
 EQS Group-Ad-hoc: Polyphor AG / Key word(s): Study 
Polyphor receives approval to start first-in-human clinical trial of inhaled 
antibiotic murepavadin 
 
22-Dec-2020 / 07:30 CET/CEST 
Release of an ad hoc announcement pursuant to Art. 53 KR 
The issuer is solely responsible for the content of this announcement. 
 
_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:* 
 
*For Investors:* 
 
Hernan Levett           Mary-Ann Chang 
Chief Financial Officer LifeSci Advisors 
Polyphor Ltd.           Tel: [phone] 
[phone]        [e-mail] 
[e-mail] 
 
*For Media:* 
 
Bernhard Schmid 
LifeSci Advisors 
[phone] 
[e-mail] 
 
*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 [1]. 
 
*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. 
 
End of ad hoc announcement 
Language:    English 
Company:     Polyphor AG 
             Hegenheimermattweg 125 
             4123 Allschwil 
             Switzerland 
Phone:       [phone] 
Fax:         [phone] 
E-mail:      [e-mail] 
Internet:    www.polyphor.com 
ISIN:        CH0106213793 
Valor:       POLN 
Listed:      SIX Swiss Exchange 
EQS News ID: 1156777 
 
End of Announcement EQS Group News Service 
 
1156777 22-Dec-2020 CET/CEST 
 
 
1: https://eqs-cockpit.com/cgi-bin/fncls.ssp?fn=redirect&url=ee6c0538a597dfcdf52d3305a6c85670&application_id=1156777&site_id=vwd&application_name=news

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December 22, 2020 01:30 ET (06:30 GMT)