Second Genome announced the first patient has been dosed in a Phase 2 clinical trial evaluating SGM-1019 for the treatment of nonalcoholic steatohepatitis (NASH). SGM-1019 is a first-in-class, oral, small molecule inhibitor of P2X7, a receptor that is involved in inflammasome activation and mediates inflammation and fibrosis.

"There are no approved therapies for NASH at this time, and, while there are many in development, SGM-1019 is directed at the inflammation underlying this condition," said Stephen Harrison, Medical Director of Pinnacle Clinical Research and the study's Principal Investigator. "We know that inhibiting P2X7 results in significant reduction in inflammation and fibrosis in preclinical models of disease and look forward to seeing the data from this study. SGM-1019 has the potential to provide a much needed treatment option for the growing number of patients with NASH."

The Phase 2a randomized, double-blind, placebo-controlled study of SGM-1019 will enroll 100 patients with NASH at leading treatment centers across the United States. The trial is designed to evaluate the preliminary safety, tolerability, pharmacokinetics and efficacy of oral twice-daily dosing of SGM-1019 at two different dose levels. Top line data are expected in the first half of 2020.

"The advancement of SGM-1019 represents a significant milestone for the company, as it demonstrates our primary commitment to building a clinical-stage, diversified pipeline of small molecules, peptides, and proteins derived from our novel microbiome-based drug discovery platform," said Karim Dabbagh, president and CEO of Second Genome. "We believe 2019 will be a defining year for Second Genome, with the team, platform, pipeline and vision in place to truly make a difference in the lives of patients. In addition to continuing to advance SGM-1019, we also expect our earlier programs to deliver clinical candidate molecules and early leads in our core indications."

SGM-1019 is an oral small molecule inhibitor of the P2X7 receptor, which plays a key role in activating the inflammasome and has been implicated in causing inflammatory diseases such as NASH and inflammatory bowel disease. In numerous preclinical NASH models, inhibition of P2X7 has been shown to be protective in animals. In clinical studies in healthy volunteers, up to twice daily dosing for 2 weeks with SGM-1019 was found to be safe and fully inhibited the P2X7 receptor in whole blood.

National Institute of Diabetes and Digestive and Kidney Diseases estimates that approximately three to 12 percent of the U.S. population has nonalcoholic steatohepatitis (NASH). NASH is a subtype of nonalcoholic fatty liver disease (NAFLD) characterized by inflammation that results in fibrosis or scarring of the liver. NASH is commonly seen in patients who are overweight/obese or have other metabolic conditions such as type 2 diabetes or elevated lipids. As NASH progresses it can lead to liver cirrhosis, transplant, cancer and even death. There are no approved treatments for NASH.

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