Clinical-stage biopharmaceutical company Altimmune has completed enroling patients for its Phase II clinical trial of HepTcell for the treatment in patients with chronic hepatitis B (CHB).
The multicentre trial enroled nearly 80 subjects who were randomised into 1:1 ratio to HepTcell or placebo.
Subjects with inactive CHB and low hepatitis B surface antigen (HBsAg) levels participated in the study.
Clinical response, defined as a 1-log or greater reduction in HBsAg, is measured as primary endpoint, while changes in the levels of hepatitis B virus (HBV) DNA, pre-genomic RNA and other virologic response markers are considered as secondary endpoints of the trial.
The company is conducting HepTcell Phase II trial in 26 sites in North America, Europe and Southeast Asia.
Altimmune CEO and president Vipin Garg said: “We are pleased to have achieved this milestone in the HepTcell Phase II trial and look forward to the data readout in Q1 2024.
“In addition, we look forward to initiating our Phase IIb 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.”
HepTcell, an immunotherapeutic, consists of nine synthetic peptides representing conserved HBV sequences adjuvanted with Valneva’s TLR9-based adjuvant, IC31.
The company develops new peptide-based therapeutics to treat liver diseases and obesity.
It is also developing pemvidutide, a GLP-1/glucagon dual receptor agonist for obesity and NASH.