Afimmune announces successful completion of a Phase I safety study with bioactive lipid DS102December 18, 2015
Afimmune’s DS102 receives FDA fast track designation as an investigational treatment for patients suffering from NASH with liver fibrosisMarch 29, 2017
Dublin, Ireland, 14th April 2016: Afimmune is today presenting a late-breaking news abstract at the annual meeting of the EASL International Liver Congress in Barcelona, Spain (April 13th-17th, 2016). The abstract is entitled “DS102: A bioactive lipid for the treatment of non-alcoholic steatohepatitis (NASH)”.
The abstract highlights the significant effects of DS102 on the pathogenesis of NASH preclinically and the key end points from the company’s oral Phase I safety study completed at the end of 2015.
Noteworthy conclusions from the abstract include:
- DS102 has been proven to be anti-fibrotic and anti-inflammatory in vitro reducing key cytokines and fibrotic markers.
- DS102 has shown significant reductions in NAFLD Activity Score (NAS) in a STAM™ model of NASH. DS102 also significantly reduced fibrosis, serum Alanine Aminotransferase (ALT) and Transforming Growth Factor beta (TGF-β).
- Phase I results in healthy volunteers showed DS102 was very well tolerated with no Serious Adverse Events (SAEs) reported, thus meeting the study’s primary safety objective. Food had a significant effect on increasing the bioavailability of DS102.
Encouraged by the data, Afimmune is initiating an oral Phase IIa trial in NASH with DS102 in the UK and the US later this year.
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.
Afimmune: [email protected]ne.com