Ascentage Pharma Announces Acceptance of IND Application by China FDA for Clinical Study of Novel IAP Inhibitor to Treat Hepatitis B Infection
APG-1387's apoptosis mechanism shown to be potentially curative in preclinical studies
ROCKVILLE, Md. and HONG KONG, Jan. 8, 2018 /PRNewswire-USNewswire/ -- Ascentage Pharma, a global clinical-stage biopharmaceutical company dedicated to developing apoptosis-targeted therapies for cancers and other diseases, today announced that the China Food and Drug Administration (CFDA) has accepted the Investigational New Drug (IND) application for APG-1387, a novel small molecule IAP inhibitor for the treatment of the Hepatitis B virus (HBV) infection. APG-1387 is the first IAP inhibitor to be studied in patients with HBV in China--which accounts for approximately one-third of HBV carriers globally--and is among the first to be developed globally.
"The antiviral treatments currently in development and on the market for chronic HBV are effective at suppressing production of the virus, but lack the ability to effectively eliminate the infection, necessitating chronic use of antiviral therapies," said Jinlin Hou M.D., Principal Investigator of APG-1387, Vice Chairman of Chinese Foundation for Hepatitis Prevention and Control, Chairman of Asia-Pacific Association for the Study of Liver (APASL) 2017, former President of Society of Infectious Diseases of Chinese Medical Association (CMA), Director of Nanfang Hospital Liver Cancer of Southern Medical University. "With a unique apoptosis mechanism that includes binding to both IAP protein monomers and dimers, APG-1387 has the potential to clear HBV infection in patients."
APG-1387 is a novel and highly specific antagonist for inhibitors of Apoptosis Inhibitors (IAPs), which is independently developed by Ascentage Pharma in China. It degrades IAPs by mimicking the endogenous Smac molecule to induce programmed cell death or apoptosis. In the preclinical studies finished by Prof. Xiaoyong Zhang (Nanfang Hospital, Southern Medical University), upregulated IAPs expression in liver tissue of chronic hepatitis B patient may promote HBV-infected hepatocytes survival during immune clearance of HBV, resulted in persistent infection. APG-1387 treatment effectively targeted IAPs in both liver cells and lymphocytes, then promoted HBV-specific T cells - mediated clearance of DNA and antigens to cure HBV infection. The potential advantage of IAP inhibitors in the treatment of HBV infection, is their ability to preferentially eliminate infected cells without affecting healthy cells, which is largely dependent on the virus specific T cells recognition.
Commented Yifan Zhai, M.D. Ph.D., Chief Medical Officer of Ascentage: "The acceptance of our IND application in China is an important next step in our global development strategy to address the critical need for more meaningful and breakthrough HBV therapies."
Ascentage is also currently investigating APG-1387 in cancer clinical trials. It has previously completed Phase 1 dose escalation studies with APG-1387 in China and Australia in cancer and recently received IND acceptance for the drug candidate in the U.S. for the treatment of advanced solid tumors and hematologic malignancies in combination with an immuno-oncology therapy.
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SOURCE Ascentage Pharma