Terns Pharmaceuticals has reported positive results from an ongoing Phase I clinical trial of TERN-201 for the treatment of non-alcoholic steatohepatitis (NASH).
A non-alcoholic fatty liver disease (NAFLD), NASH is characterised by an excess fat build-up in the liver. It causes liver inflammation, damages liver cells, and may lead to fibrosis, cirrhosis and liver failure. The disorder currently has no approved medication.
The clinical trial identified that a single oral dose of TERN-201 on the subjects resulted in sustained, near-complete suppression of semicarbazide-sensitive amine oxidase (SSAO)-specific activity in the plasma.
SSAO is known to increase oxidative stress and encourages the growth of pro-inflammatory cells to the liver, resulting in inflammation and hepatic fibrosis.
The multiple phase, single and multiple ascending dose study is the first-in-human trial of TERN-201. It included healthy human participants.
The primary endpoints of the study are safety and tolerability. Secondary endpoints are pharmacokinetics (PK) and pharmacodynamic (PD) biomarker assessments of SSAO target engagement.
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Terns president and CEO Weidong Zhong said: “These clinical data have further validated our belief that TERN-201 can become a valuable new treatment for patients with NASH, who currently have no approved treatment options.
“It has been demonstrated that SSAO inhibition can reduce hepatic inflammation and we believe TERN-201 has significant advantages, as it is highly selective for SSAO and which we believe could minimise off-target effects in the NASH patient population.”
TERN-201 is designed as an SSAO inhibitor to reduce oxidative stress and the recruitment of pro-inflammatory cells to the liver.
Terns chief medical officer Erin Quirk said: “We remain confident in our approach to SSAO inhibition, and we look forward to sharing the results of the second phase of the study in the near future, which will evaluate the effect of repeat dosing with TERN-201.”