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). SGM-1019 is one of the drugs being developed in the great NASH development race. Currently there are over 60 drugs in various stages of development.

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.

NASH prevalence in the US alone is estimated to be well into the millions and growing. It is poised to become the leading cause of liver transplants in 2020. Currently there are no approved medications for treating NASH. Companies with drugs in ph III trials include: Intercept (Ocaliva), Gilead, (Selonsertib), Genfit (Elafibranor), Allergan (Cenicriviroc).

The eventual market for this complex disease is forecast to be $20 billion to $35 billion. Competition to be one of the first to market is fierce.