Aligos Therapeutics to Host KOL Event to Discuss the Positive Phase 1b Data from ALG-000184 for the Treatment of CHB

Rhea-AI Summary

Aligos Therapeutics announced a virtual KOL event on July 18, 2024, featuring Dr. Mark Sulkowski to discuss positive Phase 1b data for ALG-000184 in treating chronic hepatitis B (CHB). The event will cover the unmet needs in CHB treatment, current landscape, and future development plans following positive FDA feedback. Aligos' CEO, Lawrence Blatt, highlighted the promising results of ALG-000184 monotherapy, showing significant viral suppression without breakthrough, and its superior efficacy compared to existing treatments. The KOL event aims to provide further insights into the regulatory pathway for chronic suppression.

Positive

• Positive Phase 1b data for ALG-000184 showing unprecedented reductions in all viral markers of CHB.
• ALG-000184 demonstrated efficacy in both HBeAg-positive and HBeAg-negative patients, reducing HBV DNA levels below 10 IU/mL at Week 48.
• FDA feedback supports the chronic HBV DNA suppression pathway as the primary efficacy endpoint.
• The KOL event with Dr. Mark Sulkowski aligns with Aligos' strategic development and regulatory plans.

Negative

• None.

• Key Opinion Leader (KOL) event with Dr. Mark Sulkowski to discuss his perspectives on the chronic suppression regulatory pathway and future development plans following positive feedback from the FDA to move forward with chronic HBV DNA suppression as the primary efficacy endpoint
  
• Scheduled for Thursday, July 18, 2024 at 3:00pm ET/12:00pm PT

SOUTH SAN FRANCISCO, Calif., July 10, 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 that it will host a virtual KOL event featuring Mark Sulkowski, MD, Johns Hopkins University School of Medicine, to discuss the unmet need and current treatment landscape for patients with chronic hepatitis B (CHB), positive data from the Phase 1b study of ALG-000184, development plans, and the chronic suppression regulatory pathway on Thursday, July 18, 2024 at 3:00pm ET/12:00pm PT.

“We are pleased to be hosting this KOL event with Dr. Sulkowski, as we are excited to share the recent FDA feedback on the path forward to bring our best/first-in-class molecule to patients in need of better therapies,” stated Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer at Aligos Therapeutics. “ALG-000184 monotherapy continues to show unprecedented reductions in all viral markers of CHB without viral breakthrough, with data 72 weeks that was recently presented at the EASL Congress 2024. The efficacy data to date has already demonstrated the potential for superiority compared to nucleos(t)ide analogs, reducing HBV DNA levels below 10 IU/mL in both HBeAg-positive and HBeAg-negative patients at Week 48. We look forward to providing additional details on the chronic suppression indication during the event.”

Mark Sulkowski, MD, is a Professor of Medicine, the Senior Associate Dean for Clinical Trials, and the Founding Director of the Office of Clinical Trials at the Johns Hopkins University School of Medicine. He also serves as the Director of the Division of Infectious Diseases at the Johns Hopkins Bayview Medical Center, a Deputy Director for the Johns Hopkins Institute for Clinical and Translational Research, and the Medical Director of the Viral Hepatitis Center in the Divisions of Infectious Diseases and Gastroenterology/Hepatology in the Department of Medicine. He received his MD from Temple University School of Medicine, Philadelphia, PA, pursued training in Internal Medicine at Duke University School of Medicine, Durham, NC, and completed his Fellowship in Infectious Diseases at the Johns Hopkins University School of Medicine.

To register for the KOL event, please click here. All attendees are required to register in advance for the webcast. For those who are unable to attend live, a replay will be available by clicking here.

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.

For more information, please visit www.aligos.com or follow us on LinkedIn or X.

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 is the focus of the Aligos Therapeutics KOL event on July 18, 2024?

The KOL event will discuss the unmet needs and current treatment landscape for chronic hepatitis B (CHB), along with positive Phase 1b data for ALG-000184, and future development plans.

What were the key results from the ALG-000184 Phase 1b study?

ALG-000184 showed unprecedented reductions in all viral markers of CHB without viral breakthrough, with HBV DNA levels reduced below 10 IU/mL at Week 48 in both HBeAg-positive and HBeAg-negative patients.

How did the FDA respond to Aligos Therapeutics' Phase 1b data for ALG-000184?

The FDA provided positive feedback, supporting the chronic HBV DNA suppression pathway as the primary efficacy endpoint for ALG-000184.

Who is Dr. Mark Sulkowski, featured in Aligos Therapeutics' KOL event?

Dr. Mark Sulkowski is a Professor of Medicine at Johns Hopkins University School of Medicine and an expert in clinical trials and viral hepatitis, serving as the Medical Director of the Viral Hepatitis Center.

Why is the ALG-000184 monotherapy significant for CHB treatment?

ALG-000184 monotherapy is significant because it has shown superior efficacy in reducing HBV DNA levels without viral breakthrough, potentially outperforming existing nucleos(t)ide analog treatments.