Aligos Therapeutics to Present Nonclinical and Clinical

SOUTH SAN FRANCISCO, Calif., Oct. 21, 2022 (GLOBE NEWSWIRE) — Aligos Therapeutics, Inc. (Nasdaq: ALGS), a medical stage biopharmaceutical firm centered on growing novel therapeutics to deal with unmet medical wants in viral and liver illnesses, at present introduced seven upcoming poster shows at The Liver Meeting® (November 4-8, 2022), hosted by the American Association for the Study of Liver Diseases (AASLD).

All posters, which cowl drug candidates focusing on continual hepatitis B (CHB) and nonalcoholic steatohepatitis (NASH), will probably be obtainable on the Aligos web site at Scientific Presentations & Conferences following the conclusion of the convention.

“The Liver Meeting® 2022 will showcase the breadth and depth of Aligos’ portfolio of potential treatments for CHB and the continued progress in our NASH program,” mentioned Lawrence Blatt, Ph.D., MBA, CEO and Chairman of the Board at Aligos. “We are excited to provide an update at the conference on our clinical-stage drug candidates, particularly our Class 2 capsid assembly modulator (CAM) for CHB, ALG-000184, which continues to show best-in-class declines in a variety of viral markers. We will also present preclinical data for ALG-125755, our siRNA drug candidate which is designed to reduce HBsAg and is currently being dosed in healthy volunteers in Phase 1. Finally, we are excited to share the excellent pharmacokinetic (PK) properties, well tolerated safety profile and reductions in various lipid levels we have observed after hyperlipidemic subjects received multiple doses of our thyroid hormone beta agonist, ALG-055009.”

Dr. Blatt continued, “We are also pleased to share preclinical findings for two early-stage CHB programs, including a second class of small molecule CAMs and two modalities of PD-L1 inhibitors.”

Chronic Hepatitis B

Capsid Assembly Modulator-2 (CAM-2)

Title: Safety, pharmacokinetics (PK), and antiviral exercise of the capsid meeting modulator (CAM) ALG-000184 in topics with HBeAg constructive continual hepatitis B (CHB)
Poster Number: 33693
Presenter: JinLin Hou, M.D.
Summary: In at present not handled or treatment-naïve CHB topics who had been HBeAg constructive, 100 and 300 mg of ALG-000184 given for up to 28 days was properly tolerated. Both dose ranges additionally exhibited predictable PK properties and resulted in fast and substantial declines in a number of viral markers.   Data exhibiting the results of ALG-000184 on HBV DNA, RNA and HBsAg ranges are mentioned within the poster.  

CAM-1

Title: Non-HAP class I capsid meeting modulators have distinct profiles and a differentiated mechanism of motion
Poster Number: 37007
Presenter: Yannick Debing, Ph.D.
Summary: Non-HAP (heteroaryldihydropyrimidine) CAM-1 compounds ALG-005398 and ALG-006162 have a profile that’s clearly distinct from recognized HAP CAM-1s. As optimized non-HAP CAM-1s have appropriate ADME/toxicity profiles, they signify a beautiful class of molecules for additional growth as part of potential practical remedy regimens for CHB.

Title: HAP Class I capsid meeting modulators clear hepatitis B virus-infected hepatocytes by way of core-dependent hepatocyte loss of life and subsequent proliferation
Poster Number: 36810
Presenter: Dieudoneé Buh Kum, Ph.D.
Summary: HAP CAM-1s had been proven to act by way of two mechanisms, presumably complemented by an immune response, that lead to a sustained lack of HBV-positive cells. First, HAP CAM-1s had been proven to induce hepatitis B virus (HBV) core protein (HBc) aggregation and hepatocyte apoptosis in HBc-expressing cells. Second, compensatory hepatocyte proliferation was proven to lead to an extra lack of AAV-HBV episomes.

siRNA

Title: Nonclinical efficacy, pharmacokinetic profile and pharmacokinetic/pharmacodynamic (PK/PD) correlation of ALG-125755, a GaINAc-conjugated siRNA, for practical remedy of continual hepatitis B
Poster Number: 35097
Presenter: Kusum Gupta
Summary: ALG-125755 demonstrates encouraging preclinical pharmacology, PK properties, and an extended half-life within the liver, which predicts month-to-month or much less frequent dosing in human topics.

PD-L1 inhibitor: siRNA

Title: Suppression of PD-L1 expression by a novel liver-targeted siRNA leads to potential restoration of immune responses in opposition to HBV
Poster Number: 36189
Presenter: Dawei Cai, Ph.D.
Summary: Liver-targeted PD-L1 siRNA remedy might lead to restoration of immune responses in opposition to HBV and consequent clearance of HBV an infection, which is taken into account essential for CHB remedy. Multiple siRNAs with sub-nanomolar PD-L1 mRNA inhibition EC₅₀ values have been recognized. Efforts to determine siRNAs with larger PD-L1 expression knockdown effectivity in addition to larger anti-HBV exercise are ongoing.

PD-L1 inhibitor: small molecule

Title: Discovery of liver-targeted oral PD-L1 small molecule inhibitors for the remedy of continual hepatitis B and liver cancers
Poster Number: 34890
Session Title: Novel Therapeutic Approaches Aimed at Functional Cure of Hepatitis B and D
Presenter: Tongfei Wu, Ph.D.
Summary: The authors rationally designed liver-targeted oral PD-L1 small molecule inhibitors to localize T cell activation within the liver and thereby doubtlessly mitigate systemic toxicity, towards an effort to develop higher tolerated PD1/PD-L1 inhibitors for CHB sufferers. Lead molecules developed to date present related in vivo efficacy to accepted antibodies however had been extra efficacious than antibodies in a liver metastatic tumor mannequin.

NASH

THR-β agonist

Title: Safety, Pharmacokinetics, and Pharmacodynamics of a number of ascending oral doses of ALG-055009, a thyroid hormone receptor beta agonist, in hyperlipidaemic topics
Poster Number: 2354
Presenter: Hakim Charfi, M.D.
Summary: Thyroid hormone receptor-beta (THR-β) agonist medicine have been proven to quickly scale back atherogenic lipids, lower hepatic fats content material and enhance liver histology, and thus signify a promising method to deal with sufferers with fatty liver illness. ALG-055009 is a novel THR-β agonist with excessive THR-β selectivity and efficiency. As a part of an ongoing Phase 1 examine (ALG-055009-301, or NCT05090111), in topics with hyperlipidemia, a number of each day doses of ALG-055009 given for 14 days had been properly tolerated with a positive PK profile and proof of lipid reducing exercise.

About Aligos

Aligos Therapeutics, Inc. is a medical stage biopharmaceutical firm that was based in 2018 with the mission to develop into a world chief within the remedy of viral infections and liver illnesses. Aligos is targeted on the invention and growth of focused antiviral therapies for continual hepatitis B (CHB) and coronaviruses in addition to leveraging its experience in liver illnesses to create focused therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ technique is to harness the deep experience and a long time of drug growth expertise its staff has in liver illness, notably viral hepatitis, to quickly advance its pipeline of probably best-in-class molecules.

Forward-Looking Statement

This press launch accommodates forward-looking statements throughout the that means of the U.S. Private Securities Litigation Reform Act of 1995. Any statements on this press launch that aren’t historic information could also be thought-about “forward-looking statements,” together with with out limitation, statements concerning ALG-000184 persevering with to present best-in-class declines in a wide range of viral markers; and with respect to ALG-055009, the PK properties being glorious, the protection profile being properly tolerated and the reductions in numerous lipid ranges being noticed after hyperlipidemic topics obtained a number of doses of ALG-055009. Forward-looking statements are sometimes, however not all the time, recognized by means of phrases comparable to “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and different related terminology indicating future outcomes. Such ahead trying statements are topic to substantial dangers and uncertainties that would trigger our growth applications, future outcomes, efficiency, or achievements to differ materially from these anticipated within the forward-looking statements. Such dangers and uncertainties embody with out limitation dangers and uncertainties inherent within the drug growth course of, together with Aligos’ clinical-stage of growth, the method of designing and conducting medical trials, the regulatory approval processes, the timing of regulatory filings, the challenges related to manufacturing drug merchandise, Aligos’ means to efficiently set up, shield and defend its mental property, different issues that would have an effect on the sufficiency of Aligos’ capital sources to fund operations, reliance on third events for manufacturing and growth efforts, modifications within the aggressive panorama and the results on our business of the worldwide COVID-19 pandemic and the continuing battle between Russia and Ukraine. For an extra description of the dangers and uncertainties that would trigger precise outcomes to differ from these anticipated in these forward-looking statements, in addition to dangers relating to the business of Aligos on the whole, see Aligos’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 4, 2022 and its future periodic experiences to be filed or submitted with the Securities and Exchange Commission. Except as required by legislation, Aligos undertakes no obligation to replace any forward-looking statements to replicate new info, occasions or circumstances, or to replicate the incidence of unanticipated occasions.

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