Terns Pharmaceuticals Highlights Clinical Data from Multiple NASH Programs in Five Presentations at the EASL International Liver Congress™ 2022

Rhea-AI Summary

Terns Pharmaceuticals presented positive results from its Phase 1 trial of TERN-501 at the EASL International Liver Congress 2022. The treatment was well-tolerated and showed significant dose-dependent effects on key biomarkers after 14 days. The company also highlighted its pipeline, including TERN-101 and TERN-201, with promising data supporting their potential in treating non-alcoholic steatohepatitis (NASH). Terns announced they will initiate a combination NASH trial with TERN-501 and TERN-101, with results expected in late 2023.

Positive

• Phase 1 trial of TERN-501 showed significant dose-dependent effects on biomarkers.
• TERN-501 was well-tolerated with no discontinuations in the trial.
• Positive clinical data for TERN-101 presented, with favorable safety profile and no discontinuations.
• Initiation of the first combination NASH trial with TERN-501 and TERN-101 planned for late 2023.

Negative

• None.

-Oral presentation of data from Phase 1 first-in-human trial of TERN-501, demonstrating treatment was well-tolerated and resulted in significant dose-dependent effects on key target engagement biomarkers

-Additional presentations to detail clinical data from Tern’s extensive pipeline, including TERN-101 and TERN-201

FOSTER CITY, Calif., June 22, 2022 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates to address serious diseases such as non-alcoholic steatohepatitis (NASH), obesity and cancer, today announced that results from clinical trials of TERN-501, TERN-101 and TERN-201 will be highlighted in several presentations at the European Association for the Study of the Liver (EASL) International Liver Congress™ (ILC) 2022, taking place June 22-26 in London, United Kingdom. The Company’s presentations will include four posters and one oral presentation.

The oral presentation titled “Multiple doses of thyroid hormone receptor-beta agonist TERN-501 were well-tolerated and resulted in significant dose-dependent changes in serum lipids and sex hormone binding globulin in a first-in-human clinical study,” will be delivered by Cara Nelson, Ph.D., senior director of clinical pharmacology at Terns, on Saturday, June 25 at 6:15 p.m. BT. This presentation will highlight results from the multiple ascending dose (MAD) cohort of the Phase 1 clinical trial of TERN-501 in healthy volunteers with mildly elevated low-density lipoprotein cholesterol (LDL-c). 3, 6 and 10 mg of TERN-501 administered for 14 days was overall safe and well-tolerated with no study drug discontinuations and significant, dose-dependent increases in sex hormone binding globulin, a marker of THR-β target engagement in the liver that has been associated with liver fat content reductions and histopathologic improvements in THR-β treated NASH patients. This study supports further investigation of TERN-501 for NASH treatment alone or in combination with other agents.

“As we continue to build momentum across our diverse pipeline, it is encouraging to see the growing body of late-stage clinical evidence supporting the THR-β class, including our candidate TERN-501, as a potential treatment for NASH. We are particularly excited to have initiated the first-ever combination NASH trial of a THR-β agonist alone and in combination with our FXR agonist, with top-line data expected in the second half of 2023,” said Erin Quirk, M.D., president and head of research & development at Terns.

Data are also being presented from the Phase 2a LIFT study of TERN-101, the Company’s liver-distributed farnesoid X receptor (FXR) agonist. LIFT was a multicenter, randomized, double-blind, placebo-controlled study evaluating 5, 10 and 15 mg doses of TERN-101 in 100 adult patients with non-cirrhotic NASH for 12 weeks. Terns reported positive top-line results from the LIFT study in June 2021. LIFT was the first 12-week controlled trial in NASH to show significant improvements in cT1, a marker of fibro-inflammation linked to clinical outcomes, and the first FXR agonist trial to demonstrate no discontinuations due to adverse events (AEs), including pruritus. Presentations at ILC 2022 highlight additional details on safety data for TERN-101 including lipid, pruritus and COVID-19 profiles, as well as pharmacokinetic (PK) and pharmacodynamic (PD) results.

A second clinical presentation titled “Favorable lipid and pruritus profile of liver-distributed farnesoid X receptor agonist TERN-101 at clinically efficacious doses in non-alcoholic steatohepatitis phase 2a LIFT study” will be delivered by Kris Kowdley, M.D., Director of Liver Institute Northwest. This presentation will detail the favorable LDL-c, high-density lipoprotein cholesterol (HDL-c) and pruritus profiles observed during the trial.

A third clinical presentation titled “Liver-distributed farnesoid X receptor agonist TERN-101 demonstrates potent target engagement with a favorable exposure-response profile in non-alcoholic steatohepatitis patients” will be delivered by Cara Nelson. This presentation will detail additional PK, PD target engagement biomarkers and favorable exposure-response relationships from the LIFT trial.

A fourth clinical presentation titled “TERN-101, a farnesoid X receptor agonist, demonstrated similar safety and efficacy in non-alcoholic steatohepatitis patients with coronavirus disease of 2019 (COVID-19) exposure compared to those with no COVID-19 exposure in phase 2a LIFT study” will be presented by Kris Kowdley. Data from the LIFT study, which was conducted during the COVID-19 pandemic, showed that the TERN-101 safety profile and cT1 responses were similar between the subset of patients with COVID-19 exposure and those without.

Terns is also presenting additional results from Part 1 of the Phase 1b AVIATION Trial of TERN-201 in patients with NASH. In a fifth clinical presentation titled “Favorable safety profile of TERN-201, a highly selective inhibitor of vascular adhesion protein-1, in the non-alcoholic steatohepatitis phase 1b AVIATION study” to be presented by Mazen Noureddin, M.D., M.H.Sc., Director of Fatty Liver Program at Cedars-Sinai Medical Center, findings showed that TERN-201 was well-tolerated with a safety profile similar to placebo.

A full list of ILC 2022 presentation abstracts can be found in the July supplement of the Journal of Hepatology.

About Terns Pharmaceuticals
Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates to address serious diseases such as NASH, obesity and cancer. Terns’ pipeline includes four clinical stage development programs including a THR-β agonist, an allosteric BCR-ABL inhibitor, an FXR agonist, a VAP-1 inhibitor, and a preclinical small-molecule GLP-1 receptor agonist program. For more information, please visit: www.ternspharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements about Terns Pharmaceuticals, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including those related to the Company’s expectations of timing and potential results of the Company’s clinical trials and other development activities, such as the Phase 2a combination trial of TERN-501 and TERN-101; the potential indications to be targeted by the Company with its single-agent and combination therapy candidates; the therapeutic potential of the Company’s single-agent and combination therapy candidates; the potential for the mechanisms of action of the Company’s product candidates to be therapeutic targets for their targeted indications; the potential utility and progress of the Company’s product candidates in their targeted indications, including the clinical utility of the data from and the 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 as compared to other products or product candidates; and the Company’s plans for and ability to continue to execute on its current clinical strategy. All statements other than statements of historical facts contained in this press release, including statements regarding the Company’s strategy, future financial condition, future operations, future trial results, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of 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 current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results and the implementation of the Company’s plans to vary materially, including the risks associated with the initiation, cost, timing, progress, results and utility of the Company’s current and future research and development activities and preclinical studies and clinical trials. In particular, the impact of the COVID-19 pandemic on the Company’s ability to progress with its research, development, manufacturing and regulatory efforts, including the Company’s clinical trials for its product candidates, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the United States and in other countries, and the effectiveness of actions taken globally to contain and treat the disease. These risks are not exhaustive. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s SEC reports, 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 period ended March 31, 2022. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.

Contacts for Terns

Investors
Justin Ng
investors@ternspharma.com

Media
Jenna Urban
Berry & Company Public Relations
media@ternspharma.com

FAQ

What were the results of the TERN-501 Phase 1 trial?

The Phase 1 trial of TERN-501 demonstrated that the treatment was well-tolerated, showing significant dose-dependent effects on key biomarkers after 14 days.

When will the combination trial of TERN-501 and TERN-101 begin?

The first combination NASH trial of TERN-501 and TERN-101 is planned, with top-line data expected in the second half of 2023.

What is the significance of the positive results from TERN-101's LIFT study?

The LIFT study was the first controlled trial in NASH to show significant improvements in cT1, a marker of fibro-inflammation, with no patient discontinuations due to adverse events.

What is Terns Pharmaceuticals focusing on?

Terns Pharmaceuticals is focused on developing treatments for serious diseases like NASH, obesity, and cancer, with multiple clinical-stage therapy candidates.