Polyphor announces protocol agreement with the FDA for the second pivotal Phase III study of murepavadin Mittwoch, 24. Oktober 2018 - 07:00

Polyphor AG / Key word(s): Regulatory Admission
Polyphor announces protocol agreement with the FDA for the second pivotal
Phase III study of murepavadin

24-Oct-2018 / 07:00 CET/CEST
Release of an ad hoc announcement pursuant to Art. 53 KR
The issuer is solely responsible for the content of this announcement.

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Allschwil, Switzerland, October 24, 2018

Polyphor announces protocol agreement with the FDA for the second pivotal
Phase III study of murepavadin

Polyphor has started PRISM-UDR Phase III clinical trial of the
pathogen-specific antibiotic murepavadin in patients with nosocomial
pneumonia and expects to begin recruitment by Q119.

Polyphor announced today that it has reached agreement with the U.S. Food
and Drug Administration (FDA) on protocol for its PRISM-UDR Phase III
clinical study of murepavadin. The study has started with the first centers
being enrolled. The study evaluates murepavadin for the treatment of
nosocomial pneumonia due to Pseudomonas aeruginosa. Polyphor expects to
recruit the first patient by Q119.

PRISM-UDR is a global Phase III multicenter, sponsor blinded, randomised,
active-controlled, parallel-group, non-inferiority study of murepavadin
combined with ertapenem in adult patients with nosocomial pneumonia due to
Pseudomonas aeruginosa. The primary efficacy objective is to demonstrate
non-inferiority (20% non-inferiority margin) of murepavadin compared to an
anti-pseudomonal β-lactam-based antibiotic.

The study was designed based on feedback from the U.S. Food and Drug
Administration (FDA) and is agreed as the basis for a potential approval in
the US. With the agreed protocol, the FDA requested not to proceed with an
interim analysis for the intention of stopping the trial early due to the
small sample size. Therefore, the basis for a potential registration in the
United States will be the completion of the single pivotal Phase III study,
PRISM-UDR. Eligible subjects with a high probability of nosocomial pneumonia
due to Pseudomonas aeruginosa will be allocated at random to receive
murepavadin or a comparator beta-lactam agent in a 1:1 ratio. The miTT
population will comprise 210 evaluable subjects (105 subjects per arm) with
nosocomial pneumonia confirmed to be due to Pseudomonas aeruginosa.

For more information about the PRISM-UDR clinical trial of murepavadin,
please visit www.clinicaltrials.gov (Identifier: NCT03582007)

"Collaborating and reaching agreement with the FDA on the design of our
pivotal trial for potential registration in the U.S. has been a priority for
Polyphor. We are pleased to have reached this milestone as we are fully
committed to the development of murepavadin that may lead to a paradigm
shift in the treatment of nosocomial pneumonia due to Pseudomonas
aeruginosa," said Giacomo Di Nepi, Chief Executive Officer of Polyphor. "We
now look forward to enrolling the first patients."


About Murepavadin (POL7080)
Murepavadin is Polyphor's most advanced product candidate and the first
OMPTA in clinical development. It is being developed for the treatment of
nosocomial pneumonia (including both hospital-acquired (HABP) and
ventilator-associated bacterial pneumonia (VABP)) due to Pseudomonas
aeruginosa and has been granted Qualified Infectious Disease Product (QIDP)
and fast track designation from the U.S. Food and Drug Administration (FDA)
for the treatment of VABP due to Pseudomonas aeruginosa.
Murepavadin is a pathogen specific antibiotic functioning through a novel
mechanism of action involving binding to an outer membrane protein of
Pseudomonas aeruginosa. In contrast to commonly used broad-spectrum
antibiotics, murepavadin is a precision medicine and as such it supports the
growing practice known as "antibiotic stewardship" which, among other
things, seeks to reduce the excessive use of broad-spectrum products to
avoid the buildup of resistance and to preserve the microbiome of the
patients.
Based on promising Phase II results, Polyphor has agreed on a streamlined
development pathway for murepavadin with the FDA and EMA and has started its
first Phase III clinical trial.

About Polyphor
Polyphor is a clinical stage, Swiss biopharmaceutical company which has
discovered and is developing the OMPTA (Outer Membrane Protein Targeting
Antibiotics). The OMPTA are potentially the first new class of antibiotics
against Gram-negative bacteria to have reached phase III stage in the last
50 years. The company's lead product, murepavadin, (POL7080) is in Phase III
development against Pseudomonas aeruginosa - recognized as a critical
priority 1 pathogen by WHO. Polyphor is also developing an immuno-oncology
candidate, balixafortide (POL6326), which is in preparation for a pivotal
trial program in combination with eribulin in patients with advanced breast
cancer, and a pipeline of further preclinical antibiotics based on its OMPTA
platform. 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.

For further information please contact:

For Investors:

Kalina Scott
Chief Financial Officer
Polyphor Ltd.
Tel: +41 61 567 16 67
Email: IR@polyphor.com


For Media:

Alexandre Müller
Dynamics Group AG
Tel: +41 43 268 32 31
Email: amu@dynamicsgroup.ch


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