Second Genome, Inc., a leader in the development of novel medicines derived from the human microbiome, today announced the presentation of preclinical data and results from a Phase 1 study in healthy volunteers with its lead drug candidate SGM-1019, a P2X7 inhibitor currently being developed for treatment of nonalcoholic steatohepatitis (NASH). The data are being presented by G. Steven Dodson, Ph.D., of Second Genome, at the European Association for the Study of the Liver (EASL) International Liver Congress 2018 on Friday, April 13, from 5:30 p.m. – 5:45 p.m. CEST. The presentation has been selected as a “Best of International Liver Congress 2018” for the metabolic disease track.
The presentation describes that preclinical studies demonstrate that P2X7, a known activator of the NLRP3 inflammasome, is a key driver of liver inflammation and fibrosis in response to metabolic and chemical liver injury. Additionally, data from the double-blind, placebo-controlled, single and multiple dose escalation Phase 1 study in healthy volunteers show that SGM-1019 was well tolerated and substantially inhibited P2X7 mediated pharmacodynamic responses at all doses tested.
“The safety profile that we observed in healthy volunteers, combined with the anti-fibrotic effects observed across NASH and liver injury models in multiple animal species, provide compelling evidence that SGM-1019 has the characteristics necessary to advance into Phase 2 in NASH,” said Matthew McClure, MD, chief medical officer at Second Genome.
Added Glenn Nedwin, Ph.D., MoT, president and chief executive officer of Second Genome, “The Phase 2 trial of SGM-1019 in NASH patients, which we expect to initiate in 2H 2018, is a key step in the development of our clinical pipeline and growth as an organization. We will continue to advance additional programs from our pipeline of therapies identified with our microbiome drug discovery platform in multiple disease areas, including inflammatory bowel disease, immuno-oncology and autism spectrum disorders.”