SAN
FRANCISCO, July 5, 2024 /PRNewswire/ -- AusperBio
Therapeutics, Inc. and Ausper Biopharma Co., Ltd.
(collectively AusperBio), a clinical-stage biotechnology
company dedicated to advancing targeted oligonucleotide therapies,
with the goal of achieving functional cure for chronic hepatitis B
(CHB) infection, today announced significant progress in the
clinical development of its leading candidate, AHB-137. This
innovative unconjugated antisense oligonucleotide (ASO) targets all
HBV mRNA, positioning it as a potential backbone of novel therapies
to treat CHB for functional cure.
CHB, HBV functional cure, ASO, AHB-137,
clinical trials
Key Clinical Development Highlights:
As of the report date, a total of 193 participants,
including 101 CHB patients, have been enrolled in the
AHB-137 clinical studies, generating a substantial dataset for
the drug's safety and efficacy profile, and marking significant
progress since our last update in February.
- China Phase 1b study has been
successfully completed.
- Global Phase 1b patient
enrollment has concluded.
- Clinical data from both Phase 1 studies were presented in
two late-breaker posters at EASL 2024.
- Phase 2a study in China has
completed patient enrollment.
- Large-scale manufacturing of AHB-137 drug product has been
successfully completed.
"We are extremely excited by the clinical milestones the AHB-137
program has achieved in the first half of 2024," said Dr.
Guofeng Cheng, Co-founder and CEO of
AusperBio. "The safety and potency profile of AHB-137 garnered
significant recognition at EASL 2024 in Milan. The success of CMC will further enable
our clinical development for AHB-137. I am deeply grateful for the
immense support from our principal investigators, clinical staff,
the AusperBio team, and the study participants."
Dr. Chris Yang, Co-founder and
CSO of AusperBio, added, "The rapid completion of Phase 2a
enrollment positions us on an accelerated timeline to establish
AHB-137's safety and efficacy profile for treatments beyond four
weeks. We are very encouraged by the emerging data and plan to
present an interim data analysis at a major international
conference later this year."
About AHB-137
AHB-137, a novel unconjugated antisense oligonucleotide
(ASO) developed within AusperBio's proprietary Med-Oligo™
ASO technology platform, was designed to treat chronic
hepatitis B for a functional cure. Its compelling preclinical
data was highlighted at the 2023 EASL™ conference. This
novel dual-mechanism ASO is presently undergoing concurrent a Phase
1b trial across multiple
international study sites and a Phase 2 trial in China. Through a global development
strategy, AHB-137 is advancing rapidly towards the
goal of HBV cure.
About Chronic Hepatitis B
Chronic Hepatitis B infection is a liver disease estimated to
affect nearly 290 million people worldwide and is a leading
cause of major liver diseases such as liver cirrhosis and
hepatocellular carcinoma. Although current treatment options can
suppress HBV replication, achieving a cure is rare. Therefore, the
discovery of a cure for CHB with finite treatment is a serious and
urgent medical need.
About AusperBio
AusperBio is a clinical-stage biopharmaceutical company with
operations in the USA and China, dedicated to advancing oligonucleotide
and targeted delivery technologies for transformative therapies,
with an initial focus on curing chronic hepatitis B infection. The
company has developed a proprietary Med-OligoTM
ASO platform which has been shown to substantially enhance the
current ASO therapeutics, through novel insights into ASO design.
Combining with efficient targeted delivery conjugation
technologies, the modular Med-OligoTM Platform
empowers ASO therapeutics to treat a broad range of diseases,
including viral infections, metabolic conditions, genetic
disorders, and immune diseases. For more information, visit
www.ausperbio.com.
For further information, please contact:
Media
Contact
Email: info@ausperbio.com
Investor Relations Contact:
Tel: 650-888-1756 (US)
Email: growth@ausperbio.com
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SOURCE AusperBio Therapeutics Inc.