PLEDPHARMA AB: PLEDPHARMA PRESENTS RESULTS FROM STUDY ON DRUG CANDIDATE ALADOTE FOR PARACETAMOL POISONING AT A GLOBAL TOXICOLOGY CONFERENCE
Stockholm, December 13, 2018. PledPharma AB (publ) announces that the
companys Aladote Phase Ib/IIa study results has been accepted for a
poster presentation during the 58th Annual Meeting of the Society of
Toxicology in March, 2019. The principal investigator Dr James Dear will
be speaker and present the positive study results.
One of the largest global conferences in toxicology is organized by the
Society of Toxicology and takes place March 10-14, 2019 in Baltimore,
Maryland. Dr James Dear, an internationally leading paracetamol toxicity
expert, was the Principal Investigator for the Proof of Principle Phase
Ib/IIa study, conducted at the Royal Infirmary of Edinburgh and the Queens
Medical Research Institute, University of Edinburgh.
Aladote is a first-in-class drug candidate, developed to reduce liver
damage due to paracetamol poisoning. The proof of principle Phase Ib/IIa
study was completed in September 2018. The results showed that Aladote is
safe and tolerable when given together with NAC (N-acetylcysteine, standard
of care). The results also indicate that Aladote can reduce liver damage
in the current patient population based on analyses of the predefined
exploratory biomarkers Keratin-18 (K18) and microRNA-122 (miR-122) in blood
samples. PledPharma is now preparing an orphan drug application to the
Federal Drug Administration, FDA, while planning for the next step of
clinical trial is being finalised.
Paracetamol/Acetaminophen poisoning is very common but the current
therapeutic options are limited to NAC. In patients who start NAC treatment
more than 8 hours after overdose this antidote loses its effectiveness.
There is an unmet need for new therapeutic options and Aladote represents
an exciting new potential therapy says Dr James Dear, University of
We are extremely proud, being selected as one of the speakers at the
Society of Toxicology Meeting. It is a sign of the great interest in our
drug candidate. I see presenting the study at one of the worlds largest
toxicology conferences is a confirmation of the quality of the study and
the drugs potential. says Nicklas Westerholm, CEO, PledPharma AB.