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Altimmune Announces IND Clearance for a Phase 2 Trial of HepTcell™ Immunotherapeutic for the Treatment of Chronic Hepatitis B
GAITHERSBURG, Md., June 22, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S.
About this update from Altimmune, Inc.
[{"type":"text","content":"GAITHERSBURG, Md., June 22, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to conduct a Phase 2 trial of HepTcell, a peptide-based immunotherapeutic for the treatment of chronic hepatitis B. The Company is also filing clinical trial applications in Canada, Spain, Germany and the United Kingdom. Altimmune plans to initiate a multinational trial in Q4 of this year, subject to an ongoing assessment of the impact of COVID-19 on study conduct.\n “We are pleased to have obtained IND clearance for the evaluation of HepTcell in a Phase 2 trial. HepTcell is the only investigational immunotherapeutic designed specifically to restore antiviral T cell responses against the most conserved antigenic domains of the Hepatitis B virus (HBV),” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “We believe that HepTcell could also be the key immunotherapy component of a future anti-HBV combination regimen to help break immune tolerance and achieve a functional cure.” According to World Health Organization estimates, chronic HBV affects 292 million worldwide, and nearly 900,000 people die annually of complications of the disease. There is no cure for chronic HBV, and currently available antiviral medications only control the disease and require life-long treatment. These treatments represent a significant burden for chronic hepatitis B patients, considering life-long commitment to medication and monitoring costs. If left untreated, chronic HBV infection can lead to serious health issues including cirrhosis, liver failure and liver cancer. HepTcell is an immunotherapeutic product candidate composed of nine synthetic HBV-derived peptides formulated with IC31®, a TLR9-based adjuvant from Valneva SE. The HBV peptides were designed to drive T cell responses against all HBV genotypes in patients of diverse genetic background. In the Phase 1 clinical study conducted in the United Kingdom and South Korea, three monthly injections at two dose levels of HepTcell peptides were given with and without IC31® adjuvant as add-on therapy to entecavir or tenofovir in patients with Hepatitis B e-antigen (HBeAg)-negative chronic infections. All arms were generally we...