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.
Afimmune: [email protected]