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.
Second Genome, Inc., a leader in the development of novel medicines through innovative microbiome science, announced todayit 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.
“We first identified this target using our microbiome discovery platform – seeing that it had the potential to make a critical, differentiated impact on multiple diseases with patient needs that are significantly unmet. Through further research, we saw a robust signal suggestive of therapeutic benefit in liver diseases and are excited to be moving forward with clinical evaluation in NASH,” said Glenn Nedwin, Ph.D., MoT, president and chief executive officer of Second Genome. “Beyond SGM-1019, we expect to move two more programs into clinical investigation in 2018 and 2019, targeting gastro-intestinal barrier function restoration and immune activation in treating diseases such as inflammatory bowel disease and cancer.”
About Second Genome
Second Genome’s mission is to transform lives with medicines developed through innovative microbiome science. Second Genome has built a novel microbiome technology platform, resulting in a pipeline of drug discovery, including a number of microbiome-derived proteins, peptides and metabolites, with applications across gastrointestinal disease, immuno-oncology, inflammation and metabolic diseases. Second Genome has completed more than 400 microbiome studies, analyzing more than 75,000 samples, for internal R&D, as well as for external partners across government, academia, pharmaceutical, nutrition and industrial companies. The team leverages its dynamic digital microbiome database and AI to generate insightful findings that can accelerate research programs by elucidating the role of the microbiome in human health conditions, agriculture, animal health and other industries. Please visit www.secondgenome.com for more information.