Terns Pharmaceuticals Secures $87 Million Series C Financing to Advance NASH Pipeline

Yiou Health, January 6: Recently, Terns Pharmaceuticals announced the completion of an $87 million Series C financing round. The proceeds from this round are intended to advance the clinical trials of its non-alcoholic steatohepatitis (NASH) pipeline.

This round of financing was led by Deerfield Management Company,Eli LillyEli Lilly and Company made a strategic equity investment, with participation from OrbiMed Advisors, Lilly Asia Ventures, Vivo Capital, Samsara Capital, and Suvretta Capital Management in this financing round.

Established in December 2016, Tuozhen Bio is a company dedicated to developing novel therapies for chronic liver diseases, including non-alcoholic steatohepatitis (NASH), liver fibrosis, and hepatocellular carcinoma. Through a combination of independent research and development and external licensing, Tuozhen Bio has established a comprehensive portfolio of products for chronic liver diseases, covering the spectrum from non-alcoholic fatty liver disease (NAFLD) and steatosis to NASH, and from hepatic inflammation to fibrosis.

Mr. Senthil Sundaram, CEO of Terns Pharmaceuticals, stated that the company will continue to develop new therapies that positively impact the lives of patients with non-alcoholic steatohepatitis (NASH). By 2021, three promising clinical-stage therapeutic candidates—TERN-101, TERN-201, and TERN-501—are expected to achieve significant near-term milestones. The details are as follows:

TERN-101: A Phase 2a clinical trial (LIFT study) involving approximately 96 patients with non-alcoholic steatohepatitis (NASH) is currently underway, with primary data expected in the second half of 2021. TERN-101 is a potent non-bile acid farnesoid X receptor (FXR) agonist. Studies have demonstrated that FXR activation significantly improves hepatic fibrosis in NASH patients without exacerbation of the underlying disease.

TERN-201: The Phase 1b clinical trial for NASH is expected to commence in the first half of 2021, with key data to be provided in the first half of 2022. This is a potent inhibitor of semicarbazide-sensitive amine oxidase (SSAO), also known as vascular adhesion protein-1 (VAP-1). It offers a novel therapeutic mechanism for the treatment of NASH by reducing oxidative stress and leukocyte accumulation in the liver.

TERN-501: Phase 1 first-in-human clinical trials commenced in the first half of 2021, with key data expected to be available in the second half of 2021. It is a highly potent and selective small-molecule thyroid hormone receptor beta (THR-β) agonist that rapidly lowers serum cholesterol, reverses hepatic steatosis, and improves liver inflammation and fibrosis.

Notably, in September this year, TERN-201 received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of non-alcoholic steatohepatitis (NASH). At that time, Tuozhen Biopharma had completed the Phase I clinical study of TERN-201, which demonstrated that single and multiple oral doses of TERN-201 were well tolerated in healthy subjects, with no significant safety concerns identified.

Non-alcoholic steatohepatitis (NASH) is a severe form of non-alcoholic fatty liver disease (NAFLD), caused by excessive fat accumulation in the liver. NASH is associated with chronic hepatic inflammation and hepatocellular injury, which can lead to fibrosis, cirrhosis, and ultimately hepatocellular carcinoma or liver failure.

As the prevalence of obesity climbs, the global incidence of NAFLD and NASH is rising rapidly, driving substantial growth in the market for related therapeutics. According to research by data analytics firm GlobalData, the NASH treatment market is projected to expand rapidly from 2019 to 2029, with a compound annual growth rate (CAGR) of 68.8%. Over the next decade, multiple pharmacological therapies for NASH are expected to be launched.

Currently, the only drug approved in the NASH treatment field is Saroglitazar, a PPARα/γ agonist from Zydus Cadila, which was approved in India in March 2020. Many pharmaceutical companies both domestically and internationally are actively investing in the NASH sector, including global giants such as BI and Eli Lilly.Pfizer、Gilead、AbbVie、BMS、Merck & Co., Inc., Novo Nordisk, AstraZeneca, and Takeda, among others. In addition, domestic companies with a presence in this field include Tuozhen Bio, Gilead Sciences (China), Zhongsheng Pharmaceutical, Guangshengtang, Chia Tai Tianqing, Junshengtai, HEC Group, MicroCore, Xianweida, Tasly, Kelun Pharmaceutical, PegBio, and CMS Pharmaceutical, among others.

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