DS102 was tested in an In Vivo Efficacy STAM™ model, an indication specific standard for NASH, over two different time periods, all of which demonstrated a clear potential for the treatment of NASH with DS102. The STAM™ model is created by a combination of chemical and dietary interventions in C57BL/6 mice.
Treatment with DS102 statistically significantly decreased the non-alcoholic fatty liver disease activity score (NAS), a clinical endpoint for assessing the activity of NASH. Importantly, DS102 also showed a statistically significant decrease in both liver fibrosis (a critical endpoint in liver disease and marker of organ deterioration) and alanine aminotransferase (ALT), a liver injury marker. The significant anti-NASH effects were consistently reproducible.
A programme of toxicology studies carried out to date in two animal species confirms the excellent safety profile of the compound.
The results support progressing DS102 into Phase I clinical trials in 2015 with a view to its commercial launch as a safe and effective treatment for NASH, liver disease and other fibrotic indications.
Afimmune Limited (Afimmune), headquartered in Dublin, Ireland, is a drug discovery and development company working on inflammatory conditions of the human primary organs including the liver and the lung.
Updated from DS Biopharma to Afimmune as effective from 22nd August 2016