Aligos Therapeutics Presents Clinical Data for its NASH Program and Non-Clinical Data for its Chronic Hepatitis B Portfolio at AASLD’s The Liver Meeting® 2022

Aligos Therapeutics Presents Clinical Data for its NASH Program and Non-Clinical Data for its Chronic Hepatitis B Portfolio at AASLD’s The Liver Meeting® 2022
Aligos Therapeutics

Aligos Therapeutics

ALG-055009, a THR-β agonist drug candidate in development as a treatment for NASH, demonstrated dose-dependent reductions in several atherogenic lipids and a favorable pharmacokinetic profile in subjects with hyperlipidemia

Aligos oral and poster presentations also collectively highlight new data from the company’s drug candidates targeting PD-L1 inhibition and the CAM-A (CAM-aberrant) mechanism for the treatment of chronic hepatitis B (CHB)

SOUTH SAN FRANCISCO, Calif., Nov. 4, 2022 (GLOBE NEWSWIRE) — Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical-stage biopharmaceutical company focused on developing novel therapies to address unmet medical needs in viral and liver disease, announced today that the company will present several posters and an oral presentation at The Liver Meeting® (November 4-8, 2022), hosted by the American Association for the Study of Liver Diseases (AASLD).

In particular, poster 2354 provides new data on the activity of ALG-055009, the Aligos thyroid hormone receptor beta (THR-β) agonist in development for nonalcoholic steatohepatitis (NASH). Multiple Ascending Dose (MAD) data from the ongoing Phase 1 study ALG-055009-301 (NCT05090111) demonstrate that treatment for 14 days in subjects with hyperlipidemia resulted in reduced levels of triglycerides, low-density lipoprotein (LDL) and apolipoprotein B in a generally dose-dependent manner. ALG-055009 was well tolerated and resulted in favorable dose-proportional pharmacokinetics with low inter-subject variability throughout the therapeutic range.

“We are pleased with the emerging clinical profile of ALG-055009,” said Lawrence Blatt, Ph.D., MBA, CEO and Chairman of the Board of Aligos. “THR-β agonists continue to have the potential to become a cornerstone therapy in the treatment of NASH, and ALG-055009 appears to compare favorably with other drugs in this class. In the future, we plan to evaluate its ability to reduce liver fat in NASH subjects over a twelve-week period in an internally or partnership-funded phase 2 study.”

Aligos oral and poster presentations at The Liver Meeting collectively highlight new data from the company’s drug candidates targeting chronic hepatitis B (CHB) and non-alcoholic steatohepatitis (NASH) and are available on the site Aligos website in Scientific presentations and conferences. The details of the presentation are described below.

Aligos has highlighted new Phase 1 clinical data on its CAM-E drug candidate, ALG-000184, in a separate press release.

presentation details

NASH

THR-β agonist

Title: Safety, pharmacokinetics, and pharmacodynamics of multiple ascending oral doses of ALG-055009, a thyroid hormone receptor beta agonist, in hyperlipidemic subjects.
Publication number: 2354
Presenter: Dr Hakim Charfi
Summary: See above.

chronic hepatitis B

PD-L1 inhibitor: small molecule

Title: Discovery of liver-targeted oral PDL1 small-molecule inhibitors for the treatment of chronic hepatitis B and liver cancers
Presentation number: 34890
Publication number: 26
Presenter: Tongfei Wu, Ph.D.
Summary: The authors rationally designed liver-targeted small-molecule oral PD-L1 inhibitors to localize T-cell activation to the liver and thus potentially mitigate systemic toxicity, in an effort to develop PD1/PD-L1 inhibitors. L1 better tolerated for patients with CHB. The lead molecules developed to date show in vivo efficacy similar to that of approved antibodies, but were more effective than antibodies in a liver metastatic tumor model.

PD-L1 inhibitor: siRNA

Title: Suppression of PD-L1 expression by a novel liver-targeting siRNA leads to possible restoration of immune responses against HBV
Poster number: 36189
Publication number: 1186
Presenter: Jin Hong, Ph.D.
Summary: Liver-targeted PD-L1 siRNA therapy can lead to restoration of immune responses against HBV and subsequent clearance of HBV infection, which is considered essential for the cure of CHB. Multiple siRNAs with subnanomolar PD-L1 mRNA inhibition CEfifty values ​​have been identified. Efforts are underway to identify siRNAs with higher efficiency of reducing PD-L1 expression as well as higher anti-HBV activity.

BED

Title: Non-PAH class I capsid assembly modulators have distinct profiles and a distinct mechanism of action
Poster number: 37007
Publication number: 1208
Presenter: Yannick Debing, Ph.D.
Summary: Non-PAH (heteroaryldihydropyrimidine) CAM-1 (CAM-A or CAM-aberrant) compounds ALG-005398 and ALG-006162 have a profile that is clearly distinct from known CAM-1 PAHs. The data presented here suggest that non-PAH CAM-1s may promote HBsAg reduction through a different mechanism than PAH CAM-1s. Since the optimized non-PAH CAM-1s have adequate ADME/toxicity profiles, they represent an attractive class of molecules for further development as part of potential functional cure regimens for CHB.

Title: HAP Class I capsid assembly modulators clear hepatitis B virus-infected hepatocytes through nucleus-dependent hepatocyte death and subsequent proliferation
Poster number: 36810
Publication number: 1202
Presenter: Dieudoneé Buh Kum, Ph.D.
Summary: PAH CAM-1 (CAM-A or CAM-aberrant) RG7907 in vivo and in vitro was shown to act through two mechanisms, possibly complemented by an immune response, resulting in a sustained loss of HBV-positive cells. First, RG7907 was shown to induce hepatitis B virus (HBV) core protein (HBc) aggregation and hepatocyte apoptosis in HBc-expressing cells. Second, compensatory proliferation of hepatocytes was shown to lead to further loss of AAV-HBV episomes. This represents an attractive mechanism for regimens aimed at introducing a functional cure in HCC.

siRNA

Title: Preclinical efficacy, pharmacokinetic profile, and pharmacokinetic/pharmacodynamic (PK/PD) correlation of ALG-125755, a GaINAc-conjugated siRNA, for functional cure of chronic hepatitis B
Poster number: 35097
Publication number: 1155
Presenter: Kusum Gupta
Summary: ALG-125755 demonstrates encouraging preclinical pharmacology, PK/PD properties, and a long half-life in the liver, predicting monthly or less frequent dosing in human subjects. A phase 1 study of ALG-125755 began dosing in healthy volunteers in October 2022.

About Aligos

Aligos Therapeutics, Inc. is a clinical-stage biopharmaceutical company that was founded in 2018 with a mission to become a world leader in the treatment of viral infections and liver disease. Aligos is focused on the discovery and development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses, as well as leveraging its expertise in liver disease to create targeted therapies for non-alcoholic steatohepatitis (NASH). Aligos’ strategy is to leverage its team’s deep expertise and decades of drug development experience in liver diseases, particularly viral hepatitis, to rapidly advance its portfolio of potentially best-in-class molecules.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements”, including but not limited to statements related to THR – β agonists continue to have the potential to become a cornerstone therapy in the treatment of NASH; ALG-055009 appears to compare favorably with other drugs in this class and we plan to evaluate its ability to reduce liver fat in subjects with NASH over a twelve-week period in an internally or partnership-funded Phase 2 study. Forward-looking statements are generally, but not always, identified by the use of words such as “may,” “will,” “would believe,” “intends,” “plans,” “anticipates,” “estimates,” “expects,” and other similar terminology indicating future results. Such forward-looking statements are subject to material risks and uncertainties that could cause our development programs, future results, performance or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include, but are not limited to other, risks and uncertainties inherent in the drug development process, including the clinical stage of development of Aligos, the process of designing and conducting clinical trials, regulatory approval processes, timing of regulatory submissions, challenges associated with manufacturing of pharmaceuticals, the ability of Aligos to successfully establish, protect and defend its intellectual property other matters that could affect the adequacy of Aligos’ capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape, and the effects of the global COVID pandemic on our business -19 and the ongoing conflict between Russia and Ukraine. For a more detailed description of risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks related to Aligos’ business in general, see Aligos’ Quarterly Report on Form 10. -Q filed with the Securities and Exchange Commission on November 2, 2022 and its future periodic reports to be filed or filed with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statement to reflect new information, events or circumstances, or to reflect the occurrence of unforeseen events.

Media contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Contact for investors
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

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