The data safety monitoring committee gave the approval to initiate the next cohort in the open-label, randomised, rising dose design, proof-of-principle safety and tolerability study with Aladote in patients treated with NAC for paracetamol overdose.
The study is conducted at the University of Edinburgh, Queen’s Medical Research Institute in Scotland and will involve a total of 24 patients assigned into one of 3 dosing cohorts of 8 patients.
The first cohort receiving the lowest dose of the study drug has been completed and after reviewing the safety data the monitoring committee, in a meeting held on September 13, approved to continue with recruitment for the middle dose group.
For more information, please contact:
Nicklas Westerholm, CEO, phone: +46 73 354 20 62
Nicklas.westerholm@pledpharma.se
Michaela Gertz, CFO, phone: +46 709 26 17 75
Michaela.gertz@pledpharma.se
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 www.pledpharma.se