Ascentage Pharma has published the results of a phase I study of the investigational apoptosis protein (IAP) antagonist APG-1387 in Chinese patients with chronic hepatitis B (CHB).
The results were presented at the 73rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2022).
This is the first clinical trial in the world to report the favorable safety and preliminary efficacy of an IAP antagonist for the treatment of patients with CHB.
Data from this clinical trial suggest that APG-1387 has activity against hepatitis B virus (HBV) at 12 mg and 30 mg doses and synergistic effects when combined with sequential nucleos
HBV infection is a global public health threat. The World Health Organization (WHO) estimates that approximately 300 million people worldwide are living with hepatitis B and 1.1 million die annually from hepatitis B, hepatitis C and their sequelae including liver cancer, cirrhosis and other conditions caused by chronic viral hepatitis.
70 million patients
In China, hepatitis B virus surface antigen (HBsAg) is present in 5–6% of the population, and there are approximately 70 million patients with chronic HBV infection in the country, of which 20–30 million have CHB.
A total of 77% of cases of liver cirrhosis and 84% of all cases of primary hepatocellular carcinoma are associated with HBV infections. Current guidelines recommend entecavir, tenofovir, tenofovir-alafenamide and long-acting interferon as standard anti-HBV treatment.
However, only a small percentage of patients treated long-term with these therapies can achieve HBsAg negativity and a continued immune response after treatment.
Most patients require prolonged or even lifelong treatment, representing a huge unmet medical need for safe and effective therapies that can minimize the risk of disease progression and achieve a functional cure with a relatively short duration of treatment.
Global intellectual property rights
Discovered and developed by Ascentage Pharma with global intellectual property rights, APG-1387 is an IAP antagonist that has already demonstrated anti-HBV potential in preclinical studies. Currently, the drug candidate is being evaluated in a phase II trial for the treatment of CHB patients in China.
APG-1387 can induce apoptosis (programmed death in diseased cells) and confer immune modulation in HBV-infected liver cells and has potential as a novel therapeutic for the functional treatment of CHB.
A promising approach
Jinlin Hou, director of the Center for Liver Disease and Institute of Hepatology at Southern Medical University Hospital Affiliated to Nanfang Hospital and principal investigator of the study, said: “New agents targeting HBV and its host targets are currently being researched. in full swing, while functional treatment of CHB remains a major challenge worldwide. As the principal investigator of this phase Ib study of APG-1387 in patients with CHB, I am pleased that the results of the study have been selected for an oral presentation at this year’s AASLD Annual Meeting.
“These results show that short-term treatment with APG-1387 can stimulate immune factors with clear anti-HBV activities and has synergistic effects when combined with sequential NA treatment. Existing safety and efficacy data suggest that the combination of APG-1387 with other targeted drugs is a promising therapeutic approach worthy of further study.”
Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said: “Our pioneering work evaluating IAP inhibitors for the treatment of CHB may bring much-needed change to the current treatment landscape. Data presented at this year’s AASLD Annual Meeting showed preliminary efficacy and manageable safety of APG-1387, signaling therapeutic potential as a candidate for the treatment of CHB.
“Going forward, we will continue the clinical development of APG-1387 in an effort to bring a new treatment option to CHB patients in China and around the world.”
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