Aligos Therapeutics Presents Positive Data at the EASL Congress 2024

Rhea-AI Summary

Aligos Therapeutics (Nasdaq: ALGS) announced positive data at the EASL Congress 2024, highlighting the antiviral efficacy of ALG-000184 for chronic hepatitis B (CHB). The data showed that 90% of HBeAg-positive patients had sustained HBV DNA suppression after 72 weeks of 300 mg daily oral monotherapy. In HBeAg-negative patients, 100% achieved complete suppression of HBV DNA and RNA after 60 weeks, with no viral breakthroughs reported. The treatment was well tolerated and showed a positive trend in anti-HBe antibody levels. Additionally, preclinical data demonstrated the potential of next-generation siRNAs for metabolic dysfunction-associated steatohepatitis (MASH) and CHB, as well as a novel CAM-A molecule for CHB treatment.

Positive

• 90% of HBeAg-positive CHB patients achieved sustained HBV DNA suppression after 72 weeks.
• 100% of HBeAg-negative CHB patients achieved complete HBV DNA and RNA suppression after 60 weeks.
• ALG-000184 showed no viral breakthroughs in both HBeAg-positive and HBeAg-negative CHB patients.
• Positive trends in anti-HBe antibody levels were observed, indicating potential long-term efficacy.
• ALG-000184 was well tolerated across all patient groups.
• Preclinical data showed potential for next-generation siRNAs in treating MASH and CHB.
• A novel CAM-A molecule demonstrated efficacy in preclinical CHB models.

Negative

• No new data on long-term side effects or safety beyond 72 weeks were provided.
• The data are preliminary and based on a number of subjects (10 HBeAg-positive and 11 HBeAg-negative).
• No direct comparison with the current standard of care nucleos(t)ides in a large-scale clinical trial.

Insights

Medical Research Analyst

The recent data presented by Aligos Therapeutics highlights the substantial antiviral activity of ALG-000184 for chronic hepatitis B (CHB) patients. Notably, the drug achieved an impressive 90% HBV DNA suppression in HBeAg-positive subjects and 100% in HBeAg-negative subjects over extended periods (72 weeks and 60 weeks, respectively). This kind of prolonged suppression without viral breakthrough sets ALG-000184 apart from many existing treatments.

This level of efficacy is significant, considering the chronic nature of hepatitis B and the difficulties in achieving sustained viral suppression. The lack of severe adverse effects further enhances the drug's profile, making it a promising candidate for both short-term and long-term management of CHB. Such results could potentially shift the treatment paradigm towards more effective and sustained regimens, addressing a major unmet need in hepatology.

However, while these results are promising, they are from ongoing clinical trials. Larger, more diverse patient populations will need to be tested to fully establish the drug's efficacy and safety profile. Furthermore, regulatory approvals based on these data will be critical milestones for the company.

Financial Analyst

Aligos Therapeutics' latest data presentation could have positive financial implications. Given the strong efficacy and safety profile of ALG-000184, the drug has the potential to capture significant market share in the CHB treatment landscape. The hepatitis B treatment market is projected to grow, driven by increasing prevalence and the need for more effective therapies.

If ALG-000184 continues to show positive results and gains regulatory approval, it could become a revenue driver for Aligos Therapeutics. The competitive advantage of demonstrating superior efficacy compared to existing treatments could also bolster the company's position in negotiations with payers and healthcare providers.

Investors should watch for upcoming regulatory milestones and further clinical data releases. These events could act as catalysts for stock performance. However, the risks associated with drug development, such as potential clinical setbacks or regulatory hurdles, cannot be ignored.

Market Research Analyst

The publication of data from Aligos Therapeutics at the EASL Congress 2024 marks a strategic move to solidify its presence in the hepatology market. By presenting these findings at a major conference, Aligos enhances its visibility among key opinion leaders, clinicians and potential partners.

The demonstrated efficacy in both HBeAg-positive and HBeAg-negative patients suggests a broad application for ALG-000184. This could drive higher adoption rates once the product enters the market. Additionally, the presentation of preclinical data on next-generation siRNAs and novel CAM-A molecules highlights Aligos' innovative pipeline, suggesting a long-term commitment to advancing liver disease therapeutics.

Given the competitive landscape of the hepatitis B market, differentiating factors such as improved efficacy, safety and the potential for combination therapy with current standards of care could position ALG-000184 favorably. Market reception to these data will be important in determining Aligos’ eventual market penetration and revenue generation capabilities.

SOUTH SAN FRANCISCO, Calif., June 05, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced positive data from six poster presentations at the European Association for the Study of the Liver (EASL) Congress 2024, being held June 5-8 in Milan, Italy.

The clinical poster presentations highlight the continued potent antiviral activity of ALG-000184 for chronic hepatitis B (CHB) in both HBeAg-positive and HBeAg-negative subjects.

Data from ≤72 weeks following an oral daily dose of 300 mg ALG-000184 monotherapy demonstrated sustained HBV DNA suppression (<LLOQ <10 IU/mL) in 9/10 (90%) HBeAg-positive CHB subjects with no viral breakthrough. New data also showed that as HBeAg declined to near negativity in this patient population, anti-HBe antibody (HBeAb) levels exhibited a positive trend.

Reported for the first time were antiviral and safety data in HBeAg-negative CHB subjects who received a daily single dose of 300 mg ALG-000184 monotherapy for ≤60 weeks. In all 11 subjects (100%), complete suppression of HBV DNA (<LLOQ 10 IU/mL) and RNA (<LLOQ 10 copies/mL) were noted, with reduction in HBcrAg levels indicating inhibition of HBV replication, as well as inhibition of cccDNA establishment/replenishment. In both patient populations, ALG-000184 continues to be well tolerated with no viral breakthrough.

“We designed ALG-000184 as a highly potent agent that could deliver broad antiviral efficacy in hepatitis B patients, regardless of their HBeAg status,” stated Lawrence Blatt, PhD, MBA, Chairman, President & CEO of Aligos Therapeutics. “These new data in HBeAg-negative CHB patients complement the broad antiviral activity we have already reported in HBeAg-positive CHB patients, with data now up to 72 weeks showing 90% of subjects achieved HBV DNA suppression. The extent of HBV DNA suppression observed to date in both CHB patient populations appear to exceed those reported by the current standard of care nucleos(t)ides, leading us to believe this is a best/first-in-class molecule.”

Additionally, other preclinical poster presentations demonstrate the potential of next generation siRNAs for treating metabolic dysfunction-associated steatohepatitis (MASH) and CHB as well as a novel CAM-A molecule for the treatment of CHB.

Details of the presentations are as follows:

ALG-000184: Potential best-in-class small molecule CAM-E for chronic hepatitis B (CHB)

Title: Extended Treatment of HBeAg+ CHB Subjects with the Capsid Assembly Modulator ALG-000184 with or without Entecavir is Associated with Reductions in Viral Markers and Favorable Anti-HBeAb trends
Presenter: Professor Man-Fung Yuen, MBBS, MD, PhD, DSc, Chair and Chief of the Division of Gastroenterology and Hepatology, University of Hong Kong
Date/Time: June 5, 2024 at 8:30am CEST

Title: Dosing with the Capsid Assembly Modulator ALG-000184 in Untreated HBeAg Negative CHB Subjects Results in Potent Antiviral Effects Including Suppression of HBV DNA/RNA and Declines in HBcrAg Levels
Presenter: Kosh Agarwal, MBBS, MRCP (UK), MD, FRCP (Ed), FRCP (London), Consultant Hepatologist and Transplant Physician, Institute of Liver Studies, King’s College Hospital NHS Foundation Trust
Time: June 5, 2024 at 8:30am CEST

Title: Association of baseline characteristics and plasma ALG-001075 to HBsAg responses in HBeAg+ CHB subjects following ALG-000184±ETV treatment
Presenter: Kha Le, PhD
Time: June 5, 2024 at 8:30am CEST

Preclinical

Title: In vitro and in vivo pharmacological characterization of human PNPLA3-targeting short interfering RNA molecules for the treatment of metabolic dysfunction-associated steatohepatitis
Presenter: Jieun Song, PhD
Time: June 6, 2024 at 8:30am CEST

Title: Second generation HBV siRNAs with novel chemistries demonstrate improved profiles compared with ALG-125755 and other clinical stage siRNAs
Presenter: Jin Hong, PhD
Date/Time: June 8, 2024 at 8:30am CEST

Title: Non-HAP CAM-A ALG-006746 and ALG-006780 induce rapid HBsAg reductions in
AAV-HBV mice and have favorable pharmacokinetic profiles
Presenter: Yannick Debing, PhD
Date/Time: June 8, 2024 at 8:30am CEST

The presentations can be found on the Scientific Presentations & Conferences section of the Aligos website (www.aligos.com) after the live event.

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 liver and viral diseases. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver and viral diseases to discover and develop potentially best-in-class therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) and viruses with high unmet medical need such as hepatitis B and coronaviruses.

Forward-Looking Statements

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 without limitation, statements regarding Aligos’ financial results and performance as well as research and development activities, including regulatory status and the timing of announcements and updates relating to our regulatory filings and clinical trials. 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’ clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, and other matters that could affect the sufficiency of Aligos’ capital resources to fund operations. 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’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2024 and its future periodic reports to be filed or submitted 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.  

Investor Contact
Jordyn Tarazi
Vice President, Investor Relations & Corporate Communications
+1 (650) 910-0427
jtarazi@aligos.com

Media Contact
Michael Fitzhugh
LifeSci Communications
mfitzhugh@lifescicomms.com

FAQ

What new data did Aligos Therapeutics present at EASL Congress 2024?

Aligos presented data showing that ALG-000184 achieved 90% HBV DNA suppression in HBeAg-positive CHB patients and 100% HBV DNA and RNA suppression in HBeAg-negative CHB patients.

How effective is ALG-000184 for HBeAg-positive CHB patients?

ALG-000184 demonstrated 90% sustained HBV DNA suppression in HBeAg-positive CHB patients after 72 weeks of treatment.

What results were observed in HBeAg-negative CHB patients treated with ALG-000184?

In HBeAg-negative CHB patients, ALG-000184 achieved 100% suppression of HBV DNA and RNA after 60 weeks, with no viral breakthroughs.

Were there any safety concerns reported for ALG-000184?

ALG-000184 was well tolerated in both HBeAg-positive and HBeAg-negative CHB patients with no viral breakthroughs reported.

What other potential treatments did Aligos present data on?

Aligos presented preclinical data on next-generation siRNAs for MASH and CHB, and a novel CAM-A molecule for CHB treatment.