Hepatitis B is a serious liver infection and a global health threat caused by the development of chronic infection in a proportion of patients who are unable to clear the virus and become carriers. It increases a person’s risk of developing liver cancer, liver failure, and/or cirrhosis for which no effective curative treatments are available. Two billion people around the world have been infected with the hepatitis B virus, with approximately 1.5 million people becoming newly infected each year. Approximately 300 million people are suffering from the chronic hepatitis B infection.
In collaboration with Erasmus MC and using ISA’s Synthetic Long Peptide (SLP®) technology, ISA has developed ISA104 immunotherapy. ISA104 is designed to create a strong and specific immune response against HBV, with the aim to functionally cure chronically infected patients. In July 2021 Erasmus MC and ISA were awarded a Private-Public Partnerships (PPP) Allowance made available by Health~Holland, Top Sector Life Sciences & Health, to conduct a first-in-human, phase 1 study of ISA104. This study is named the HEB-PEP study.
The HEB-PEP study is currently enrolling patients. It investigates the safety, tolerability and efficacy of different doses of ISA104 in chronic HBV patients versus placebo. Details of the study can be found at clinicaltrials.gov under identifier NCT05841095. The study is conducted in close collaboration with investigators of the Gastroenterology & Hepatology department of the Erasmus MC in Rotterdam, the sponsor of the study. Please contact us at info@isa-pharma.com for more information about the HEB-PEP study.