Debiopharm International SA Initiates a Clinical Trial Phase II study evaluating afabicin in Bone and Joint Infections

Lausanne, Switzerland (ots) - Debiopharm International SA
(Debiopharm - www.debiopharm.com/debiopharm-international/), part of
Debiopharm Group(TM), a Swiss-based global biopharmaceutical company,
today announced the start of a clinical phase II study to evaluate
its antibiotic afabicin (Debio 1450) ( http://ots.ch/mejSrV ) for the
treatment of staphylococcal bone and joint infections (NCT03723551) (
https://clinicaltrials.gov/ct2/show/NCT03723551 ).

This study, a randomized open-label active-controlled trial, will
assess the safety, tolerability, and efficacy of afabicin IV/oral in
the treatment of patients with bone or joint infection (BJI). In this
global clinical study with sites in Ukraine and the US, 60 patients
will be treated with afabicin or comparator up to 12 weeks. The
primary endpoints of the study are safety and tolerability. A range
of efficacy measures such as number of responders, resolution of
disease specific signs and symptoms, improvement of inflammation and
microbiological eradication of the baseline pathogen will be assessed
as secondary endpoints. As this is an open label study, data will be
available as the study progresses. Depending on recruitment
completion is expected mid-2020.

"This trial is a key step forward for afabicin clinical
development, but even more for patients suffering from severe bone
and joint infections who are left with too few treatment options.
Remember that afabicin is a first in class selective Staphylococcus
aureus antibiotic and that Staphylococcus aureus is responsible for
most of the BJI infections. So specifically targeting the responsible
bug is not only providing a new ammunition against a well-known high
priority pathogen, but it is also embracing latest stewardship
program and treatment trends that all point to a better use of
antibiotics." - Mahdi Farhan, Medical Director at Debiopharm
International

About afabicin

afabicin (Debio 1450) is a first-in-class new antibiotic
benefiting from both oral and intravenous (IV) formulations. It is a
highly potent, Staphylococcus-selective antibiotic with a low
propensity to develop resistance. This FabI inhibitor is also active
against staphylococci strains which are resistant to the current
standard-of-care antibiotics such as beta- lactams, vancomycin,
daptomycin or linezolid. Debio 1450, perfectly suited to tackle
several hard-to-treat infections, is now studied in Bone & Joint
infections (BJIs) caused by staphylococci. For more information:
https://patients.debiopharm.com/bone-joint-infection/

About Debiopharm International SA

Part of Debiopharm Group(TM), Debiopharm International SA is
focused on the development of prescription drugs that target unmet
medical needs. The company in-licenses and develops promising drug
candidates. The products are commercialized by pharmaceutical
out-licensing partners to give access to the largest number of
patients worldwide. For more information, please visit
www.debiopharm.com/debiopharm-international/

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Pressekontakt:
Christelle von Büren
Communication Coordinator
christelle.vonburen@debiopharm.com
Tel: +41 (0)21 321 01 11

Original-Content von: Debiopharm International SA, übermittelt durch news aktuell