- AHB-137 gains Breakthrough Therapy Designation (BTD) from
the NMPA based on Phase 1/Phase2a clinical trial data demonstrating
safety and efficacy.
- BTD accelerates AHB-137's development and regulatory
review, facilitating potential access for chronic hepatitis B
patients.
- Chronic HBV affects 296 million people globally,
with a rare cure and is the primary cause of liver
cancer.
SAN
FRANCISCO, July 10, 2024 /PRNewswire/
-- AusperBio Therapeutics, Inc. and Ausper Biopharma
Co., Ltd. (collectively AusperBio), a clinical-stage
biotechnology company dedicated to advancing targeted
oligonucleotide therapies for achieving functional cure in chronic
hepatitis B (CHB) infection, today announced that their
investigational drug AHB-137 has received Breakthrough Therapy
Designation (BTD) from the Center for Drug Evaluation
(CDE) of the National Medical Products Administration
(NMPA) of China. This
designation accelerates AHB-137's development and potential access
for patients.
Breakthrough Therapy Designation (BTD),
AHB-137, Chronic Hepatitis B, Functional Cure, Clinical Trial
The BTD was supported by clinical evidence from two parallel
trials evaluating AHB-137's safety and efficacy in treating CHB
patients, a Phase 1/2a trial conducted in China
(chinadrugtrials.org.cn #CTR20232098;
clinicaltrials.gov #NCT06115993) and a Phase 1 trial
conducted outside China
(clinicaltrials.gov #NCT05717686). Results from these trials
were presented in two late-breaker posters at the European
Association for the Study of the Liver (EASL) Congress 2024 in
Milan, Italy.
Bella Lu, Regulatory Affairs
Director at AusperBio, underscored that the BTD provides
AHB-137 with expedited review status by the CDE, enabling timely
communication and accelerated approval to address critical clinical
needs. BTD does not change product approval standards but
significantly expedites the regulatory process.
" We are delighted by the NMPA's grant of Breakthrough Therapy
Designation for AHB-137. This approval recognizes the promising
clinical data collected to date and highlights the urgent need for
substantial advancements in CHB treatment options," said
Bella Lu. "The outstanding safety
and efficacy results from our Phase 1/2a studies suggest that
AHB-137 has the potential to improve upon current HBV therapies.
With NMPA's support, we aim to accelerate AHB-137's development
further."
About NMPA Breakthrough Therapy Designation
The Breakthrough Therapy Designation (BTD) is part of the
recently revised Drug Registration Regulation, effective from
July 1, 2020. The NMPA BTD program
aims to accelerate the development and evaluation of medicines for
serious or life-threatening diseases. This designation is granted
based on preliminary clinical evidence indicating that the
investigational therapy may offer substantial improvement over
available therapies on at least one clinically significant
endpoint. For a list of drugs granted BTD by NMPA, please click
here.
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-Oligo™ 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-Oligo™ Platform empowers ASO therapeutics
to treat a broad range of diseases, including viral infections,
metabolic conditions, genetic disorders, and immune diseases.
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.