Enrollment complete in 2 Phase 2 trials testing hepatitis B treatment
Earlier trials show AHB-137 suppresses HBV
Enrollment is complete in two Phase 2 clinical trials testing Ausperbio’s AHB-137 in people with chronic hepatitis B, the company said.
That “positions us well as we move into the pivotal Phase III study of AHB-137, which was recently approved in China,” said Chris Yang, PhD, co-founder and chief scientific officer of Ausperbio, said in a company press release. Pivotal trials are those designed to produce results that, if positive, will be used to support submission for a therapy’s regulatory approval.
“We are excited and committed to advancing new treatment options with the goal of bringing a functional cure to a broader population of patients living with [hepatitis B],” Yang said.
Ausperbio expects to present interim results from the Phase 2 trials at scientific conferences next year.
Financing to aid development
The company recently announced $63 million in financing to support the therapy’s development, including the pivotal Phase 3 trial, several Phase 2 trials testing AHB-137 combinations, and expansion of Phase 2 testing to sites outside China.
“This financing positions us to accelerate the pivotal development of AHB-137, expand our global clinical footprint, strengthen our platform and pipeline, and advance our long-term vision of delivering a functional cure for people living with chronic hepatitis B and beyond,” Guofeng Cheng, PhD, Ausperbio’s co-founder and CEO, said in a separate press release.
The hepatitis B virus (HBV), the cause of hepatitis B, infects the liver and promotes inflammation. Chronic or long-lasting HBV infection can set the stage for life-threatening complications like liver cancer.
AHB-137 is a small piece of genetic material called an antisense oligonucleotide that’s designed to prevent the production of certain viral proteins needed for HBV to survive.
Data from earlier China-based studies, including a Phase 1/2a trial (NCT06115993) and a Phase 2b trial (NCT06550128), showed that the therapy can safely and effectively suppress HBV in people with chronic infections.
Recruitment is complete for two other AHB-137 Phase 2 trials in people with chronic hepatitis B. One, AB-10-8007 (NCT07069569), is testing AHB-137 in combination with other hepatitis B treatments in patients taking other therapies.
The other trial, AB-10-8008 (NCT06829329), is testing the therapy on its own and in combination with antiviral treatment in people with chronic hepatitis B who have never received antiviral treatment.
In both studies, the main goal is to evaluate the proportion of patients who have no detectable HBV proteins or genetic material after about six months and/or six months after discontinuation of all treatments.
“The AB-10-8007 study aims to combine AHB-137 with approved [hepatitis B] treatments to further increase functional cure rates, while the AB-10-8008 study explores the potential to expand AHB-137 treatment to a broader patient population,” Cheng said. “Together, these studies could further establish AHB-137 as the potential backbone therapy for [hepatitis B] functional cure.”
Cheng said testing AHB-137 in combination with other treatments is important because “combination therapies have historically been a key to treat or cure chronic viral infections” including hepatitis C and human immunodeficiency virus (HIV).
The company did not provide further details on the design of the Phase 3 trial in China. Data, if positive, could be used to support AHB-137’s approval for people with chronic hepatitis B.
Ausperbio said earlier this year that it had raised $50 million to advance the development of AHB-137.
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