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: +44 7483 284 853
+41 61 567 16 00 mchang@lifesciadvisors.com
IR@polyphor.com
*For Media:*
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 [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: +41 61 567 1600
Fax: +41 61 567 1601
E-mail: info@polyphor.com
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
(END) Dow Jones Newswires
December 22, 2020 01:30 ET (06:30 GMT)