Aligos Therapeutics presents positive data at AASLD Liver Meeting® 2023 demonstrating that treatment with ALG-000184 (CAM-E) significantly reduces hepatitis B antigens (HBsAg, HBcrAg and HBeAg)

Hepatitis B virus and antigen-positive (HBeAg+) subjects took 300 mg ALG-000184 once daily + Treatment with entecavir for up to 48 weeks demonstrated:

• Dose-dependent mean reduction up to 2 log₁₀ IU/mL of HBV antigen

• Average DNA reduction up to 6.8 log₁₀ International units/ml

• Non-viral DNA breakthrough in subjects receiving ALG-000184 monotherapy

• Data suggest ALG-000184 may reduce cccDNA levels through two mechanisms of action of CAM-E drugs

• Well tolerated safety profile

SOUTH SAN FRANCISCO, Calif., Nov. 10, 2023 (GLOBE NEWSWIRE) — Aligos Therapeutics, Inc. (Nasdaq: ALGS) is a clinical-stage biopharmaceutical company focused on developing novel therapies to treat liver and , a company with unmet medical needs in viral diseases, today announced that emerging hepatitis B antigen reduction data for its capsid assembly modulator-Empty (CAM-E) drug ALG-000184 has been featured as a latest poster in U.S. Liver Research Published at The Liver Meeting® (AASLD), November 10-14, 2023 in Boston, MA.

Poster (#5028-C),”Long-term administration of the capsid assembly modulator ALG-000184 results in several-fold reductions in DNA, RNA, HBsAg, HBeAg and HBcrAg in untreated HBeAg-positive chronic hepatitis B subjects” can now be accessed at The Liver Meeting® and in the Scientific Presentations and Meetings section of the Aligos website (www.aligos.com). The data will be presented by Hong Kong on Monday, November 13, from 1 to 2 p.m. ET Dr. Man-Fung Yuen, chairman and professor of the University’s Department of Gastroenterology and Hepatology, announced in Poster Hall C.

Key highlights from the poster summarize the safety and antiviral activity data of ALG-000184 300 mg once daily in HBeAg-positive subjects + Entecavir (ETV) x ≤48 weeks, including:

1. HBsAg, HBeAg and HBcrAg decreased by an average of 1.2 log₁₀ SI units/ml, 1.7 log₁₀ PEI U/L and 2.0 log₁₀ U/mL respectively at week 48. These reductions were dose-dependent and independent of co-administration of ETV, suggesting that ALG-000184 may be effective via 1^Yingshi and 2^{Unknown date.} Mechanism of action of CAM-E drugs

2. A greater average DNA reduction was observed for ALG-000184 + ETV vs. ETV monotherapy after 12 weeks; maximum mean DNA reduction was 6.8 log₁₀ IU/mL observed for ALG-000184 + ETV combination at Week 48

3. The average DNA reduction was comparable with 300 mg of ALG-000184 with or without ETV, indicating that ETV does not further affect DNA reduction.No viral DNA breakthrough observed in subjects receiving ALG-000184 monotherapy

4. ALG-000184 was well tolerated with or without ETV and no safety signals were identified

The story continues

“I have been one of the physicians overseeing the Phase 1a/1b study of ALG-000184 for many years and have been impressed by the antiviral activity demonstrated by ALG-000184, particularly in HBeAg+ subjects,” noted Dr. Yuen. “ALG-000184 appears to have best-in-class antiviral properties, which is also unique compared to other drug classes being evaluated for the treatment of chronic hepatitis B (CHB). If the trends observed to date continue, ALG -000184 has the potential to become a cornerstone therapy in the treatment of CHB. “I look forward to sharing these exciting data at the Liver Meeting. “

“Efforts to increase functional cure rates and improve outcomes in patients with chronic hepatitis B have been very challenging,” said Ira Jacobson, MD, director of liver disease research at New York University. “We believe that more deeply suppressing the virus or enhancing the immune response to the virus , or a combination of both may be necessary. The antiviral effects of ALG-000184 demonstrated at AASLD suggest that the drug may achieve significant viral suppression by inhibiting cccDNA synthesis. If these effects persist, ALG-000184 may be associated with The combination of complementary mechanisms of action may bring us one step closer to achieving higher rates of functional cure.”

“We are pleased to see reductions in all HBV viral markers associated with long-term administration of ALG-000184, with or without entecavir,” said Lawrence Blatt, PhD, MBA, chairman and CEO of Aligos Therapeutics. , all continue to show such a favorable trend.” “The data suggest that ALG-000184 is the first CHB drug to affect cccDNA antigen expression levels through two mechanisms of action and may play a central role in future efforts to achieve higher rates of chronic DNA suppression or functional cure. Therefore, We have initiated Phase 2 support activities to prepare for future studies and look forward to continuing to share new data from these ongoing cohorts at future scientific meetings. We are proud of our team for this important achievement, We also thank our collaborator at Emory University (Professor Raymond Schinazi) for his contribution to this work.

About Arrigos

Aligos Therapeutics, Inc. is a clinical-stage biopharmaceutical company founded in 2018 with a mission to become a world leader in the treatment of liver and viral diseases. Aligos’ strategy is to leverage its team’s deep expertise and decades of drug development experience in liver and viral diseases to discover and develop drugs targeting non-alcoholic steatohepatitis (NASH) and viruses with high unmet medical need, such as potential best treatments for coronaviruses and chronic viruses). Hepatitis B (CHB).

forward-looking statements

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be deemed “forward-looking statements,” including, without limitation, that mean HBsAg, HBeAg, and HBcrAg reductions were dose-dependent, independent of coadministration of ETV, indicating that ALG-000184 may Pass 1^Yingshi and 2^{Unknown date.} Mechanism of action of CAM-E drugs; ALG-000184 appears to have first-in-class antiviral properties that are unique compared to other drug classes being evaluated for the treatment of CHB, and if the trends observed to date continue, ALG-000184 has Potential to become a cornerstone therapy for the treatment of chronic hepatitis B; Believe that deeper suppression of the virus or an enhanced immune response to the virus or a combination of both may be necessary; The antiviral effects of ALG-000184 suggest that the drug may act by inhibiting cccDNA synthesis Achieving more significant viral suppression, if these effects are sustained, ALG-000184, combined with a complementary mechanism of action, may bring us a step closer in an effort to achieve higher functional cure rates; stated data suggest ALG-000184 is the first to pass Two CHB drugs whose mechanisms of action affect cccDNA antigen expression levels and may play a central role in future efforts to achieve higher rates of chronic DNA suppression or functional cure; the company looks forward to sharing ongoing cohorts at future scientific meetings new data. Forward-looking statements are often, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate” and other similar words. “Expectations” and other similar terms referring to future results. Such forward-looking statements are subject to significant risks and uncertainties that could cause our development plans, 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, risks and uncertainties related to market conditions, risks and uncertainties inherent in the drug development process, including the clinical development phase of Aligos, the process of designing and conducting clinical trials, regulatory the approval process, the timing of regulatory filings, the challenges associated with manufacturing drug products, Aligos’ ability to successfully establish, protect and defend its intellectual property rights, other matters that may affect the adequacy of Aligos’ capital resources to fund operations, reliance on third parties for manufacturing and development efforts , and the impact of global events and other macroeconomic conditions on Aligos’ business. 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 the overall risks associated with Aligos’ business, see Aligos’ quarterly report on Form 10-Q filed with the SEC on November 2, 2023 and future periodic reports it will file with the SEC. Aligos does not undertake to update any forward-looking statements except as required by law. An obligation to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.

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