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The data demonstrated that treatment with TERN-501 resulted in time- and dose-dependent increases in sex hormone binding globulin (SHBG), a key marker related to the histological efficacy of NASH.
Phase 2a DUET trial evaluating TERN-501 alone and in combination with TERN-101, the first trial evaluating THR-β and FXR agonists in NASH, is ongoing
FOSTER CITY, Calif., Nov. 4, 2022 (GLOBE NEWSWIRE) — Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: SUIT), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to treat serious diseases, including oncology, obesity and non-alcoholic steatohepatitis (NASH), today announced that the company is reporting positive clinical data from its Phase 1 study of TERN-501, a thyroid hormone receptor beta (THR-β) agonist in development for the treatment of NASH. The results are highlighted in a poster presentation at The Liver Meeting®, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), taking place November 4-8, 2022.
The poster presentation, by Cara Nelson, Ph.D., senior director of clinical pharmacology at Terns, highlights the results of a Phase 1 study in which healthy participants with low-density lipoprotein (LDL) cholesterol levels of 100-190 mg/dL were randomized (3:1) to receive TERN-501 (1, 3, 6, or 10 mg) or placebo once daily for 14 days. The results showed that among the 24 treated participants, TERN-501 was generally well tolerated and exhibited dose-dependent pharmacokinetics with low variability. Participants treated with TERN-501 also experienced time-dependent increases in sex hormone binding globulin (SHBG), a key pharmacodynamic marker of THR-β compromise related to decreases in atherogenic lipid levels and histologic efficacy of NASH. and dose and highly associated with exposure to TERN-501. Results showed that 0%, 0%, 33.3%, 83.3%, and 100% of subjects in the placebo, TERN-501 1, 3, 6, and 10 mg groups, respectively, had increases in SHBG ≥ 75% at day 15 compared to baseline.
In TERN-501 recipients, results also showed dose-dependent decreases in total cholesterol, LDL cholesterol, and apolipoprotein-B levels, with greater median percent decreases at day 15 in recipients who had SHBG increases ≥ 75 % than those who had
“The presented data from our Phase 1 study reiterate that TERN-501 has a predictable pharmacokinetic profile with low variability and treatment results in robust increases in SHBG and lipid-lowering effects. TERN-501 is a promising candidate for the treatment of NASH, either as a monotherapy or in combination with other agents,” said Kerry Russell, MD, Ph.D., medical director of Terns. “We look forward to continuing evaluations of TERN-501, including our ongoing phase 2a DUET trial of TERN-501, alone and in combination with our FXR agonist TERN-101, with first-line data expected in the second half of 2023. ”.
Terns will review the ongoing Phase 2a DUET trial (NCT05415722) design and objectives in a second presentation at The Liver Meeting. DUET is the first trial to evaluate the safety and efficacy of a THR-β agonist and farnesoid X receptor (FXR) agonist combination regimen in patients with NASH. The DUET trial will evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of TERN-501 administered alone and in combination with TERN-101 in approximately 140 non-cirrhotic NASH patients over 12 weeks. The primary endpoint will be the relative change in liver fat content as measured by MRI protein density fat fraction (PDFF) at week 12 for TERN-501 monotherapy compared to placebo.
About Terns PharmaceuticalsTerns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small molecule product candidates to treat serious diseases, including oncology, obesity and NASH. Terns’ pipeline includes four clinical-stage development programs including a BCR-ABL allosteric inhibitor, a THR-β agonist, an FXR agonist, a VAP-1 inhibitor, and a receptor agonist preclinical program. small molecule GLP-1. For more information please visit: www.ternspharma.com.
About TERN-501TERN-501 is a thyroid hormone receptor beta (THR-β) agonist with high metabolic stability, improved hepatic distribution, and higher selectivity for THR-β compared to other THR-β agonists in development. THR-β agonism increases fatty acid metabolism through mitochondrial oxidation and affects cholesterol synthesis and metabolism. As a result, THR-β stimulation has the ability to reduce hepatic steatosis and improve serum lipid parameters, including LDL cholesterol and triglycerides. Terns reported single ascending and multiple ascending positive dose (SAD/MAD) data of phase 1 proof-of-concept clinical trial in November 2021. Phase 2a clinical trial of DUET of TERN-501 alone and in combination with TERN-101 is ongoing, with first-line data expected in the second half of 2023.
About TERN-101TERN-101 is a non-bile acid-containing, liver-distributing FXR agonist that has demonstrated a differentiated tolerability profile and better target interaction, likely due to its sustained activation of FXR in the liver, but only because of its sustained activation of FXR in the liver. a transient activation of FXR in the intestine. FXR is a nuclear receptor that is expressed primarily in the liver, intestine, and kidneys. FXR regulates the hepatic expression of several genes involved in lipid metabolism, inflammation, and fibrosis. Clinical studies of other FXR agonists have shown significant histologic improvements in NASH, but have also resulted in pruritus, adverse lipid changes, and discontinuations. Terns reported positive results results of the Phase 2a LIFT study of TERN-101 in June 2021.
Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements about Terns Pharmaceuticals, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of federal securities laws, including those regarding expectations of the Company of the timing and potential results of clinical trials and other Company development activities, such as the Phase 2a DUET trial of TERN-501 alone and in combination with TERN-101; the possible indications to which the Company will address with its product candidates; the therapeutic potential of the Company’s product therapy candidates; the potential of the mechanisms of action of the Company’s product candidates to be therapeutic targets for their specific indications; the potential utility and progress of the Company’s product candidates in their specific indications, including the clinical utility of the data and endpoints used in the Company’s clinical trials; the Company’s clinical development plans and activities; the Company’s expectations regarding the profile of its product candidates, including tolerability, safety, metabolic stability, and pharmacokinetic profile and potential differentiation compared to other products or product candidates; and the Company’s plans and ability to continue to execute its current clinical strategy. All statements other than statements of historical fact contained in this press release, including statements about the Company’s strategy, future financial condition, future operations, future test results, projected costs, prospects, plans, management objectives and expected market growth are forward-looking statements. looking for statements. In some cases, you can identify forward-looking statements by terminology such as “target,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “should,” ” estimate”, “expect”, “goal”, “intend”, “may”, “target”, “plan”, “position”, “potential”, “predict”, “seek”, “should”, “target” , “will”, “would” and other similar expressions that are predictions or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its expectations, estimates, current forecasts and projections about future events and financial trends that you believe may affect your financial condition, results of operations, business strategy and financial needs In light of the material uncertainties in these forward-looking statements, you should not rely on the forward-looking statements such as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results and implementation of the Company’s plans to vary materially, including risks associated with the initiation, cost, timing, progress, results and profit of the Company’s current and future research and development activities and preclinical studies and clinical trials. These risks are not exhaustive. For a detailed discussion of risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s SEC filings, including, but not limited to, its Annual Report on Form 10-K. for the year ended December 31, 2021 and its Quarterly Report on Form 10-Q for the periods ended March 31, 2022 and June 30, 2022. Except as required by law, the Company does not assume any obligation to publicly update any forward-looking statement for any reason.
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Source: Terns Pharmaceuticals, Inc.