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First patient included in PledPharma’s clinical trial with Aladote®

June 8, 2017

PledPharma AB
Company Announcement

First patient included in PledPharma's clinical trial with Aladote®

Stockholm, 2017-06-08 15:45 CEST (GLOBE NEWSWIRE) -- 
Today, PledPharma announces that the first patient has been included in the
clinical study with Aladote® - a drug candidate intended to reduce the acute
liver damage associated with acetaminophen/paracetamol poisoning. 

Acetaminophen is one of the most commonly used drugs for treatment of fever and
pain but at the same time one of most commonly used drugs in both deliberate
and accidental overdoses. Intentional overdose of acetaminophen is one of the
most common method for suicide attempts among adolescents aged 10-19 years.
Today there is no effective treatment of the significant proportion of patients
(approximately 25%) who seek medical care only in the later stages of the
poisoning process. 

The first patient has now been included in a clinical proof of principle study,
conducted in collaboration with the University of Edinburgh under the direction
of Dr James Dear, one of the leading doctors in the treatment of patients
overdosing acetaminophen. 

The aim of the study is to document the compound's safety and tolerability as
an adjunct to current standard treatment (N-acetylcysteine) for the prevention
of acute liver failure. 24 patients is expected to be included in the study. 

Dr James Dear, principal investigator and Reader in Pharmacology at the
University of Edinburgh, commented ˝During the first 24 hours after paracetamol
poisoning people usually experience few or no symptoms. Therefore, many
patients come to hospital at such a late stage that the current standard
treatment is not sufficient to prevent acute liver failure. Calmangafodipir,
one of the components of Aladote, has in preclinical studies demonstrated
impressive results even in the late stages of the poisoning process, and I look
forward to the results of this important proof-of-principle study”. 

For more information, please contact:

Jacques Näsström, CEO, phone: +46 737 130 979

Michaela Gertz, CFO, phone: +46 709 26 17 75

About PledPharma

PledPharma develops new drugs that protect the body against oxidative stress –
a potentially debilitating and sometimes life-threatening condition that can be
caused by chemotherapy treatment and following acetaminophen (paracetamol)
overdose. The company's most advanced project PledOx® is being developed to
reduce nerve damage associated with chemotherapy. A phase IIb study has been
conducted and will serve as the basis for the continued development. The drug
candidate Aladote® is being developed to reduce the risk of acute liver failure
associated with acetaminophen poisoning. PledPharma (STO: PLED) is listed on
Nasdaq First North. Erik Penser Bank is the company’s Certified Adviser (tel
+46 8 463 80 00). For more information, see 

This information is information that PledPharma AB (publ) is obliged to make
public pursuant to the EU Market Abuse Regulation. The information was
submitted for publication, through the agency of the contact person set out
above, on June 8, 2017



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Phone: +46 8 679 72 10