Altimmune Inc. (NASDAQ:ALT) announced that the FDA approved its IND application to carry out the second phase HepTcell study in chronic hepatitis B treatment.
Altimmune filed clinical trial applications in the UK, Canada, Spain, and Germany. The company will initiate the multinational HepTcell study in 4Q 2020, which depends on assessing the effect of the COVID-19 pandemic
HepTcell to restore antiviral T cell responses
Vipin Garg, the CEO and President of Altimmune, stated that they were delighted to obtain the IND approval for HepTcell evaluation in a second phase study. Garg asserted that HepTcell was the only immunotherapeutic treatment designed to restore antiviral responses of T cell against Hepatitis B virus’ (HBV) antigenic domains. He added that there is potential of HepTcell being a vital immunotherapy constituent in an anti-HBV combination regimen that can break immune tolerance.
World Health Organisation (WHO) estimates that there are close to 292 million cases of chronic HBV globally, and almost 900,000 people die yearly due to complications resulting from the disease. There is no available cure for chronic HBV, and the current antiviral therapies are meant only to control the ailment and need life-long medication. As a result, the treatments represent a huge burden for HBV patients because of monitoring costs and life-long treatment commitment. Most importantly of untreated chronic HBV can result in serious health problems such as liver cancer, liver failure, and cirrhosis.
HepTcell combination with IC31® adjuvant well tolerated
HepTcell, an immunotherapeutic treatment, is derived from nine synthetic HBV peptides formulated from Valneva SE’s TLR9 adjuvant, IC31®. The peptides are designed to induce T cell responses against HBV genotypes for patients with varied genetic backgrounds. The company conducted phase 1 trials in the UK and South Korea with three monthly injections at two HepTcell peptide dose levels administered with IC31® adjuvant and without. There was better tolerance in both study arms with both the low and high HepTcell doses administered in combination with the IC31® adjuvant showing strong T cell responses against HBV antigens.