Aligos Therapeutics Announces Pipeline Update and Upcoming Presentations at the European Association for the Study of the Liver’s Digital International Liver Congress 2021

June 14, 2021 at 8:00 AM EDT

-Five scientific posters to be presented at upcoming EASL ILC meeting
- All 4 Aligos CHB development candidates continue to advance – STOPS™ molecule and CAM drug candidates are currently being evaluated in CHB subjects - ASO and siRNA drug candidates are on track to enter clinical development in H2 2021 and H1 2022, respectively
-Antiviral activity data from at least one cohort of CHB patients for ALG-010133 and ALG-000184 expected to be presented in H2 2021

SOUTH SAN FRANCISCO, Calif., June 14, 2021 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical-stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that the company will present five abstracts highlighting data from the company’s chronic hepatitis B (CHB) therapeutic programs. The presentations will take place at the European Association for the Study of the Liver (EASL) Digital International Liver Congress™ 2021 (ILC 2021), which is being held virtually on June 23-26, 2021. Important information for these posters can be found below.   

Additionally, the company today announced a CHB portfolio update to highlight the progress made with the four development programs. Aligos reported that both its capsid assembly modulator (CAM) drug candidate and the S-antigen Transport-inhibiting Oligonucleotide Polymers (STOPS™) molecule drug candidate have now completed Phase 1a studies in healthy volunteers and are currently being evaluated in CHB patients in Phase 1b studies. We expect to present preliminary data from these Phase 1b studies in H2 2021. Once Phase 1b studies are completed, we plan to advance these drug candidates into Phase 2 studies in H2 2022 to identify combination regimens that could potentially result in enhanced rates of functional cure. Following closely behind the STOPS and CAM programs, Aligos’ antisense oligonucleotide (ASO) and small interfering RNA (siRNA) drug candidates continue to advance through nonclinical development and are on track to start Phase 1 trials in H2 2021, and H1 2022, respectively.  For additional details, see the Chronic Hepatitis B Portfolio Summary below.

Aligos’ upcoming poster presentations at EASL’s ILC 2021 are summarized below.   

S-antigen Transport-inhibiting Oligonucleotide Polymers (STOPS™)
Poster number: 1305
Title: Mechanism of Action of Hepatitis B Virus S-antigen Transport-Inhibiting Oligonucleotide Polymers (STOPS™) Molecules
Presenter: Cheng Kao

Poster number: 1004
Title: Safety, Tolerability and Pharmacokinetics (PK) of Single and Multiple Doses of ALG-010133, an S-Antigen Transport Inhibiting Oligonucleotide Polymer (STOPS™) for the Treatment of Chronic Hepatitis B
Presenter: Ed Gane

Capsid Assembly Modulators (CAMs)
Poster number: 1386
Title: Capsid Assembly Modulator ALG-000111 and its Prodrug ALG-000286 Display Excellent In Vitro and In Vivo Antiviral Activity
Presenter: Yannick Debing

Small Interfering Ribonucleic Acids (siRNA)
Poster number: 1196
Title: ALG-125755, A Small Interfering RNA (siRNA) Against Hepatitis B Virus (HBV) Effectively Inhibits Hepatitis B Surface Antigen (HBsAg) Secretion in HBV Cell Models and the AAV-HBV Mouse Model
Presenter: Jin Hong

Combination of Small Interfering RNA (siRNA) and Antisense Oligonucleotides (ASO)
Poster number: 1257
Title: Combination Drug Interactions of Hepatitis B Virus (HBV) Small Interfering RNA (siRNA) and Antisense Oligonucleotides (ASO) In Vitro and In Vivo
Presenter: Hua Tan

These posters will be available on demand to conference attendees throughout the conference. They will also be available on the “Scientific Presentation and Publications” page in the “Presentations” section of Aligos’ website at shortly after they are presented at the conference.   


Chronic Hepatitis B Portfolio Summary
ALG-010133 (STOPS) and ALG-000184 (CAM)
ALG-010133 and ALG-000184 are each being evaluated in separate Phase 1 trials (NCT04485663 and NCT04536337) that include an evaluation in healthy volunteers (Phase 1a) followed by an evaluation in CHB patients (Phase 1b). The healthy volunteer portions of each study have been completed and the company is evaluating the drug candidates in CHB patients in both trials. In the case of the STOPS candidate, accomplishing at least a 1.0 log10 IU/mL mean reduction in HBV S-antigen levels after 12 weeks of weekly dosing is the targeted level of antiviral activity considered necessary to move into Phase 2 development. For the CAM drug candidate, preliminary antiviral activity data in treatment naïve (not previously treated) CHB subjects were promising, showing a mean HBV DNA reduction of 2.9 log10 IU/mL at Day 14 (Gane et al., HBV TAG 2021) and the drug was well tolerated. Data from patient cohorts for each drug candidate are planned for presentation at an upcoming medical conference in late 2021.   

ALG-020572 (ASO)
Aligos is developing ALG-020572, an ASO candidate that contains nucleotide stabilization chemistry in-licensed from Luxna Biotech Inc., Ltd. The company has nearly completed Phase 1 enabling nonclinical studies and has identified a lead candidate, which has demonstrated greater HBV S-antigen reduction compared to another known ASO drug candidate in clinical development in the HBV-AAV mouse model. The company plans to advance ALG-020572 into Phase 1 clinical studies in H2 2021.

ALG-125755 (siRNA)
Similarly, Aligos is developing ALG-125755, a novel siRNA using proprietary chemistry.    In nonclinical studies, ALG-125755 demonstrated greater HBsAg reductions compared to another known drug candidate in clinical development in the HBV-AAV mouse model. Aligos plans to advance its lead clinical candidate into the clinic in H1 2022.

About Aligos
Aligos Therapeutics, Inc. is a clinical-stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. 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 diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline 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 regarding our expectation to present preliminary data from the Phase 1b studies of our CAM drug candidate and the STOPS™ molecule drug candidate in H2 2021; our plan, once Phase 1b studies are completed, to advance these drug candidates into Phase 2 studies in H2 2022; our ASO and siRNA drug candidates being on track to start Phase 1 trials in the second half of 2021, and the first half of 2022, respectively; our planned presentation of data from patient cohorts for each of the CAM and STOPS drug candidate at an upcoming medical conference in late 2021; our plans to advance ALG-020572 into clinical studies in the second half of 2021; and our plans to advance ALG-125755 into the clinic in the first half of 2022.    Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward-looking statements are subject to substantial 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 without limitation risks and uncertainties inherent in the drug development process, including Aligos’s clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Aligos’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the effects on our business of the worldwide COVID-19 pandemic. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2021, as well as other documents Aligos files from time to time with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.

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