Data from the POP study support further development of Aladote® as a new treatment option for reducing liver damage due to paracetamol overdose
March 26, 2019
Stockholm, March 26, 2019. PledPharma AB (publ) today announces further data from the Proof of Principle (POP) study. Patients in need of additional NAC infusions after the planned 12 hrs of NAC infusion were 50% for the NAC-alone group and 11% for the NAC+Aladote® group.
The scientific rationale as well as clinical results from the completed POP study indicate that Aladote® in combination with N-acetylcysteine (NAC) has the potential to reduce liver damage in the specified patient population. Results in summary:
- Aladote® is safe and tolerable in patients treated with NAC for paracetamol overdose
- Aladote® may reduce liver toxicity after paracetamol overdose
- Biomarkers for hepatic liver injury:
- All patients with NAC alone had an increase in both K18 isoforms which is consistent with liver cell death.
- K18 (Patients with decreased levels from baseline to 20hrs: n (%)): NAC alone: 0 (0%); NAC+Aladote: 6 (33%)
- CCK18 (Patients with decreased levels from baseline to 20hrs: n (%)): NAC alone: 0 (0%); NAC+Aladote: 7 (39%)
- miR-122 (Patients with decreased levels from baseline to 20hrs: n (%)): NAC alone: 2 (33%); NAC+Aladote: 11 (61%)
- Patients in need of additional NAC infusions after the planned 12 hrs NAC infusion, n (%): NAC alone: 3 (50%); NAC+Aladote: 2 (11%)
PledPharma intends to conduct regulatory interactions to determine the next step in development of Aladote®.
Dr James Dear, principal investigator, will be presenting the results at PledPharma’s capital markets day. Dr Dear, an internationally leading paracetamol toxicity expert, was the Principal Investigator for the POP study, conducted at the Royal Infirmary of Edinburgh and the Queen’s Medical Research Institute, University of Edinburgh.
“We are very pleased to see indications of clinical relevance through the reduced need for continued NAC in patients treated with Aladote®. This has the potential to reduce hospital stay in this patient population. With these encouraging results and the recent orphan drug designation for Aladote® we are committed to continue the development of Aladote®.” says Nicklas Westerholm, CEO PledPharma AB.