Terns Pharmaceuticals, Inc., a multinational biopharmaceutical corporation committed to the discovery and development of novel therapies for the treatment of non-alcoholic steatohepatitis (NASH) and cancer, today announced the results of an ongoing phase 1 clinical trial of TERN-201, a semicarbazide-sensitive amine oxidase (SSAO) inhibitor developed for NASH. Such results were presented today at the NASH-TAG Conference held January 9-11, 2020, in Park City, Utah.
The study showed that a single oral dose of TERN-201 resulted in persistent, almost complete suppression of the plasma-specific SSAO activity. This corresponded to > 90 per cent inhibition of SSAO activity in the plasma at each dose stage tested (1 mg, 3 mg, 6 mg, and 10 mg). These decreases were observed four hours after a single dose of TERN-201 and detectable for inhibition up to a week. No adverse events or laboratory anomalies of clinical relevance were reported.
“The evidence from the single-ascending dose process of our first-in-human TERN-201 clinical study is very promising and indicates that single doses of TERN-201 result in sustained inhibition of SSAO and are very well tolerated,” said Erin Quirk, M.D., Chief Medical Officer at Terns. “We remain confident in our approach to SSAO inhibition and look forward to sharing in the near future the results of the second phase of the trial, which will evaluate the impact of repeat dosing with TERN-201.” “These clinical data further reinforced our belief that TERN-201 can become a valuable new therapy for patients with NASH who currently have no approved treatment options,” he said.
“It has been shown that SSAO inhibition can reduce hepatic inflammation and we agree that TERN-201 has significant advantages, as it is highly selective for SSAO and we believe that it could mitigate off-target effects in the NASH patient population.”
TERN-201’s first-in-human trial is a multi-phase, single-and multi-ascending study of the dose in healthy human participants. In the first phase 32 research volunteers during ascending dose cohorts receive a single dose of TERN-201 or placebo. Healthy participants are given repeated doses of TERN-201 or placebo in the second phase of the study, also in ascending dose cohorts. For each step of the trial the primary endpoint is protection and tolerability. Secondary endpoints include SSAO target engagement assessments of the pharmacokinetics (PK) and pharmacodynamic (PD) biomarker.