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.
“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.” Read More