TERN-201 NASH clinical trial : Terns Pharmaceuticals said that an ongoing phase 1 trial of its semicarbazide-sensitive amine oxidase (SSAO) inhibitor TERN-201 in non-alcoholic steatohepatitis (NASH) has yielded positive results.
According to the US biopharma company, the early-stage NASH clinical study showed that a single oral dose of TERN-201 delivered a sustained, near-complete suppression of SSAO-specific activity in the plasma. At all the level of doses studied, which includes 1 mg, 3 mg, 6 mg, and 10 mg, this corresponded to more than 90% inhibition of the SSAO activity in the plasma, said Terns Pharmaceuticals.
The reductions in the SSAO activity were seen four hours after the administration of a single dose of TERN-201 and the inhibition was detectable up to a week. The California-based biopharma company said that there were no clinically relevant adverse events or laboratory abnormalities from the TERN-201 NASH clinical trial.
Erin Quirk – Chief Medical Officer of Terns Pharmaceuticals said: “The data we have observed from the single-ascending dose phase of our first-in-human clinical study of TERN-201 are very encouraging and show that single doses of TERN-201 result in sustained SSAO inhibition and are very well tolerated.
“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.”
The findings of the TERN-201 NASH clinical study were presented by Terns Pharmaceuticals at the recently held NASH-TAG Conference in Park City, Utah.
Weidong Zhong – President and CEO of Terns Pharmaceuticals, commenting on the TERN-201 NASH clinical trial results, 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 minimize off-target effects in the NASH patient population.”
The first-in-human clinical trial of TERN-201 is a multiple phase study involving healthy human participants. The first phase has 32 study volunteers subjected to a single dose of TERN-201 or placebo in ascending dose cohorts.
In the second phase of the phase 1 NASH clinical study, healthy participants will be given repeat doses of TERN-201 or placebo, which will also be in ascending dose cohorts.
The primary endpoint for both the phases of the TERN-201 NASH clinical trial is safety and tolerability, while the pharmacokinetics (PK) and pharmacodynamic (PD) biomarker assessments of SSAO target engagement will be the secondary endpoints.