Second Genome has successfully completed a Phase 1 study in healthy volunteers for its lead therapeutic candidate, SGM-1019, a first-in-class oral therapeutic candidate for treatment of nonalcoholic steatohepatitis (NASH). SGM-1019 targets tissue injury and inflammation in the liver, a key driver of NASH progression, through inhibition of an inflammasome activation pathway identified using Second Genome's microbiome drug discovery platform.
The move forward with clinical development in NASH is supported by strong safety results from the double-blind, placebo-controlled, single and multiple dose escalation Phase 1 clinical trial, which evaluated the safety, tolerability, pharmacokinetics and target inhibition of SGM-1019 in healthy volunteers. In the study, SGM-1019 achieved targeted exposure levels and was safe and well tolerated. In addition, SGM-1019 demonstrated efficacy in a non-human primate model of liver fibrosis. Further results of these studies have been submitted for presentation at a scientific meeting in early 2018.
"Our Phase 1 results show a very favorable safety profile for SGM-1019, which is important when considering the challenges seen to date in bringing new treatments for NASH," Karim Dabbagh, Ph.D., chief scientific officer at Second Genome. "Coupled with animal models that show an excellent treatment rationale and efficacy by targeting the inflammasome to reduce hepatic inflammation and liver fibrosis, we believe this could be a significant step toward addressing the unmet need in NASH."
The company intends to advance SGM-1019 into a Phase 2 clinical trial in mid-2018. The clinical program will target non-cirrhotic NASH patients.