AusperBio Doses First Patient in Clinical Trial of AHB-171 for Chronic Hepatitis B

AusperBio Advances Its Second Clinical-Stage Hepatitis B Therapy

AusperBio Therapeutics Inc. and Ausper Biopharma Co., Ltd. have announced an important milestone in their hepatitis B pipeline. The company has started dosing the first patient in a clinical study evaluating AHB-171, an investigational small interfering RNA (siRNA) therapy designed for the treatment of chronic hepatitis B (CHB).

This marks the second clinical-stage program from AusperBio and the first therapy developed using the company's proprietary Au-HALO liver-targeting delivery technology together with its siRNA platform.

The new candidate joins the company's lead program, AHB-137, and further expands its portfolio of next-generation oligonucleotide therapies aimed at treating chronic hepatitis B.

Why This Clinical Trial Matters

Chronic hepatitis B continues to be one of the biggest infectious disease challenges worldwide.

According to the World Health Organization's Global Hepatitis Report 2024:

• Around 254 million people are currently living with hepatitis B worldwide.
• Nearly 1.2 million new infections occur every year.

Although existing antiviral medicines can control viral replication, they rarely eliminate the virus completely. As a result, researchers are still searching for treatments that can help patients achieve what is known as a functional cure.

That is the goal AusperBio hopes to move closer to with AHB-171.

What Is AHB-171?

AHB-171 is an investigational hepatocyte-targeted siRNA therapy designed specifically for chronic hepatitis B.

The treatment uses AusperBio's proprietary Au-HALO liver-targeting delivery platform, which is designed to deliver the therapy directly to liver cells where the hepatitis B virus primarily lives.

Once delivered, AHB-171 aims to:

• Reduce viral gene expression
• Provide strong antiviral activity
• Maintain long-lasting suppression of the virus

The company believes this targeted approach could become an important part of future combination therapies intended to achieve a functional cure for chronic hepatitis B.

First Clinical Candidate Using the Au-HALO Platform

The ongoing study is also an important test of AusperBio's technology platform.

AHB-171 is the first medicine developed using the company's Au-HALO liver-targeting delivery system.

Besides evaluating the therapy itself, the study will also generate valuable information about how well the delivery technology performs in patients.

If successful, the platform could be used to develop additional targeted RNA therapies for liver diseases and other conditions.

Company Sees the Trial as a Major Milestone

Dr. Guofeng Cheng, Co-founder and Chief Executive Officer of AusperBio, described the first patient dosing as a significant achievement for the company.

According to him, the milestone demonstrates AusperBio's ability to develop its own technology platforms and successfully move them into clinical development.

He also explained that AHB-171 expands the company's hepatitis B pipeline beyond its lead antisense oligonucleotide (ASO) candidate, AHB-137, and supports the company's long-term strategy of developing therapies with different mechanisms of action.

Dr. Cheng added that combining multiple therapeutic approaches may play an important role in helping patients achieve a functional cure for chronic hepatitis B.

He also thanked the patients, investigators, and clinical teams who made the study possible.

AHB-171 Is Designed to Complement Existing Programs

Rather than replacing its lead candidate, AHB-171 is intended to strengthen AusperBio's overall hepatitis B development strategy.

The company believes different oligonucleotide therapies can work together by targeting the virus through complementary mechanisms.

This approach could improve treatment outcomes and increase the chances of achieving durable viral control.

By expanding beyond a single treatment platform, AusperBio hopes to build a broader pipeline capable of addressing different aspects of chronic hepatitis B infection.

Technology Platform Takes Another Step Forward

Dr. Chris Yang, Co-founder and Chief Scientific Officer of AusperBio, said AHB-171 combines the company's proprietary siRNA discovery platform with its Au-HALO targeted delivery technology.

He explained that the therapy is designed to provide powerful and sustained suppression of hepatitis B viral gene expression while supporting future combination treatment strategies.

Dr. Yang also noted that this clinical study represents the first opportunity to evaluate both the medicine and the underlying technology platform in patients with chronic hepatitis B.

The clinical data generated from this trial is expected to guide future development of AHB-171 while also helping validate the company's liver-targeting delivery platform.

Clinical Trial Will Evaluate Safety and Early Performance

The newly initiated clinical study will primarily evaluate the safety and clinical profile of AHB-171 in patients living with chronic hepatitis B.

Researchers will also assess how effectively the therapy reaches liver cells through the Au-HALO delivery platform and whether it demonstrates the expected antiviral activity.

The results will help determine the next steps for the clinical development of AHB-171 and support future studies.

AusperBio Continues Expanding Its Hepatitis B Pipeline

AusperBio operates in both the United States and China and focuses on developing innovative oligonucleotide therapies supported by proprietary delivery technologies.

The company has built multiple technology platforms, including:

• Med-Oligo antisense oligonucleotide (ASO) platform
• Au-HALO targeted liver delivery platform
• Proprietary siRNA platform

These technologies are being used to develop new treatments for chronic hepatitis B and other diseases where targeted RNA therapies may provide improved clinical outcomes.

With the first patient now dosed, AHB-171 becomes another important step in AusperBio's effort to develop next-generation therapies aimed at achieving a functional cure for chronic hepatitis B.

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