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news.Terns Pharmaceuticals has secured fast track designation from the US Food and Drug Administration (FDA) for its TERN-101 investigational farnesoid X receptor (FXR) agonist to treat non-alcoholic steatohepatitis (NASH).
Image: The US FDA’s Centre for Drug Evaluation and Research. Photo: courtesy of The U.S. Food and Drug Administration.
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NASH is a severe form of non-alcoholic fatty liver disease (NAFLD), which results due to the accumulation of excess fat in the liver.
The disease, which is associated with chronic liver inflammation and liver cell injury, may cause fibrosis, cirrhosis, and eventually liver cancer or liver failure.
TERN-101 showed clinical pharmacokinetic properties consistent with once-daily dosing in phase 1 studies to date, said the company.
Eli Lilly initially discovered and developed TERN-101 and TERN-201, a semicarbazide-sensitive amine oxidase (SSAO) inhibitor. Both are being developed for the treatment of NASH.
In 2018, Terns entered into a global and exclusive licence agreement with Eli Lilly for the development, manufacturing and commercialisation of TERN-101 and TERN-201.
TERN-101 is a potent non-bile acid FXR agonist, which is currently under development as a therapeutic for NASH. FXR is a nuclear receptor that is mostly expressed in the liver and small intestine.
Terns chief medical officer Dr Erin Quirk said: “Receiving Fast Track Designation for TERN-101 is an important step in bringing this promising treatment to patients as soon as possible, and we look forward to working with the agency as we advance TERN-101 through clinical development.
“We are pleased that the U.S. FDA recognizes the potential for TERN-101 to address the unmet treatment need for patients with NASH, who currently have no therapeutic options.”
Terns is a clinical-stage pharmaceutical company, which is involved in the discovery and development of medicines for chronic liver disease and cancer. Based in China and the US, the company is developing a pipeline of drug candidates to treat NASH and cancer.
Earlier this month, Eli Lilly has secured FDA approval for its Reyvow (lasmiditan) for the acute treatment of migraine.
Reyvow is a new oral medication for the acute treatment of migraine, with or without aura, in adults. It binds to 5-HT1F receptors with high affinity.
