ShutterstockGAITHERSBURG, Md., April 11, 2023 — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company (the Company), today announced that it has completed enrollment in its Phase 2 clinical trial of HepTcell, an immunotherapeutic for the treatment of chronic hepatitis B (CHB). With the achievement of this milestone, data readout is planned for the first quarter of 2024.
The multicenter clinical trial, which is being conducted at 26 sites in North America, Europe and Southeast Asia, enrolled approximately 80 subjects with inactive CHB and low levels of hepatitis B surface antigen (HBsAg). Subjects were randomized 1:1 to HepTcell or placebo. The primary endpoint of the trial is clinical response, defined as a 1-log or greater reduction in HBsAg. Secondary endpoints include changes in the levels of hepatitis B virus (HBV) DNA, pre-genomic RNA and other markers of virologic response.
“We are pleased to have achieved this milestone in the HepTcell Phase 2 trial and look forward to the data readout in Q1 2024,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “In addition, we look forward to initiating our Phase 2b biopsy non-alcoholic steatohepatitis (NASH) trial in mid-2023 and announcing topline data from our 48-week MOMENTUM obesity trial in the fourth quarter of 2023.”
About HepTcell
HepTcell is a novel, investigational, immunotherapeutic comprised of nine synthetic peptides representing conserved HBV sequences adjuvanted with IC31®, a TLR9-based adjuvant from Valneva SE. The HBV-directed peptides are designed to drive T cell responses against all HBV genotypes towards a functional cure for chronic HBV in patients of diverse genetic backgrounds.
About Chronic Hepatitis B
According to World Health Organization estimates, CHB affects approximately 296 million worldwide, and over 800,000 people die annually of complications of the disease. If left untreated, CHB can lead to serious diseases including liver cirrhosis, liver failure and liver cancer. There is no cure for CHB, and currently available medications only control the disease without eradicating the infection.
About Altimmune
Altimmune is a clinical-stage biopharmaceutical company focused on the development of novel peptide-based therapeutics for the treatment of obesity and liver diseases. The Company’s lead product candidate, pemvidutide, is a GLP-1/glucagon dual receptor agonist that is being developed for the treatment of obesity and NASH. In addition, Altimmune is developing HepTcell™, an immunotherapeutic designed to achieve a functional cure for CHB. For more information, please visit www.altimmune.com.
Source : Altimmune, Inc.
Related HIV and Co-Infections News
-
Hepatitis B: Updates from Aligos Therapeutics, Arbutus Biopharma Corporation and Precision BioSciences
-
EurekAlert!: Between 2.4 and 4.1 million people estimated to be living with chronic hepatitis B infection in Europe
-
The Rockefeller University: A new mouse model of virus-driven liver cancer may open the door to better diagnosis and treatments
Get involved
Are you living with HIV/AIDS? Are you part of a community affected by HIV/AIDS and co-infections? Do you work or volunteer in the field? Are you motivated by our cause and interested to support our work?
Subscribe
Stay in the loop and get all the important EATG updates in your inbox with the EATG newsletter. The HIV & co-infections bulletin is your source of handpicked news from the field arriving regularly to your inbox.