Interim results of an ongoing phase 1 clinical trial of TERN-201, a semicarbazide-sensitive amine oxidase inhibitor for the treatment of nonalcoholic steatohepatitis, revealed a positive safety and tolerance profile, according to a press release from Terns Pharmaceuticals.
“The data observed to date from the phase 1 clinical study of TERN-201 are encouraging and show that TERN-201 has the potential to be a promising new therapy to treat NASH and liver fibrosis,” Erin Quirk, MD, chief medical officer of Terns, said in the release. “Terns has advanced two compounds into clinical development in 2019 with both TERN-201 and TERN-101, an FXR agonist, in ongoing studies. We look forward to seeing further results from the phase 1 studies of TERN-101 and TERN-201 later in the year as we progress toward our goal of introducing safe and effective combination therapies for NASH.”
According to the release, TERN-201 is a potent semicarbazide-sensitive amine oxidase (SSAO) inhibitor that provides an additional treatment mechanism for NASH by reducing oxidative stress and recruitment of white blood cells to the liver.
During the first phase of the study, participants received single oral administrations of TERN-201, which were well-tolerated with no significant safety findings or adverse events that led to discontinuation.
Additionally, each dose level resulted in decreased plasma SSAO activity compared with baseline, which was maintained up to 1 week after single dose administration. Based on these results, the study has progressed to the multiple-dose phase.