PledPharma to initiate one pivotal Phase II/III study with Aladote® for marketing authorisation application in both US and EU
January 8, 2020
Stockholm. PledPharma AB (STO: PLED) announced today that following interactions with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), the company has finalized the development program for Aladote®, a drug candidate intended to reduce liver damage associated with paracetamol poisoning. The development program consists of one pivotal Phase II/III study which is expected to be sufficient for a marketing authorisation application in both US and EU. The study is planned to be initiated mid-2020.
Aladote is a “first-in-class” drug candidate developed to prevent liver damage caused by paracetamol overdose, which has been granted Orphan Drug Designation in the US. A proof of principle study has been successfully completed, establishing safety and tolerability and providing an indication that Aladote may reduce liver injury.
Following interactions with the FDA and the EMA, PledPharma has finalized the development program for Aladote which consists of one pivotal Phase II/III study. This study is expected to be sufficient for a marketing authorisation application in both US and EU. It is targeting patients arriving late at hospital, more than 8 hours after an overdose, and for which current standard of care, N-acetylcysteine (NAC), is no longer effective. The study will consist of two stages with an interim analysis in between that includes a futility analysis and dose selection where the most effective dose will be continued.
"We are very pleased with our interactions with both the FDA and the EMA which have enabled us to finalize our development strategy for Aladote. In parallel with our interactions with the regulatory agencies to finalize specific study details, we are performing a Contract Research Organisation (CRO) selection and working on a feasibility study to enable a rapid initiation of the clinical study. We look forward to share further details about the study in due time” said PledPharma’s CEO, Nicklas Westerholm.