ISA Pharmaceuticals, a clinical-stage biotech company based in the Netherlands, has announced the initiation of a groundbreaking Phase 1 study for the functional cure of chronic hepatitis B (HBV). The study, known as HEB-PEP, aims to investigate the safety, tolerability, and efficacy of ISA104, a novel treatment designed to establish a functional cure in patients with chronic HBV.
Chronic hepatitis B is a serious liver infection and a significant global health threat. It occurs when the virus remains in a person’s body for an extended period, leading to the development of chronic infection and potentially causing liver cancer, liver failure, and cirrhosis. Currently, there are no effective curative treatments available for this condition. Globally, around two billion people have been infected with the hepatitis B virus, with approximately 1.5 million individuals becoming newly infected each year. Furthermore, an estimated 300 million people are suffering from the chronic sequelae of this disease.
The HEB-PEP study, conducted in collaboration with the Gastroenterology & Hepatology department of the prestigious Erasmus Medical Center in Rotterdam, aims to evaluate the safety, tolerability, and efficacy of different doses of ISA104 compared to a placebo in chronic HBV patients. This first-in-human (FIH) phase 1 study will provide crucial information on the potential of ISA104 as a treatment option for patients with chronic hepatitis B virus infection.
ISA104 is an immunotherapy developed by ISA Pharmaceuticals using their Synthetic Long Peptide (SLP®) technology in collaboration with Erasmus MC. The therapy is designed to elicit a strong and specific immune response against HBV, with the ultimate goal of achieving a functional cure in chronically infected patients. ISA Pharmaceuticals has previously demonstrated the effectiveness of SLP immunotherapy in patients chronically infected with human papillomavirus type 16 (HPV16).
Dr. Sonja Buschow and Dr. Dave Sprengers, Principal Investigators of the study from Erasmus MC’s Department of Gastroenterology & Hepatology, expressed their excitement about the progress made in this first-in-human trial. They are eager to determine the potential impact that ISA104-based therapy could have on patients suffering from chronic hepatitis B virus infection. The study will not only shed light on safety issues and immune responses but also deepen the understanding of this promising new therapy, HBV-directed immune responses, and novel HBV biomarkers.
Leon Hooftman, Chief Medical Officer of ISA Pharmaceuticals, expressed his delight at the enrollment of the first patient in the HEB-PEP clinical study. He emphasized the importance of developing an effective treatment for patients with chronic hepatitis B virus infection, a significant global health burden and a key cause of liver cancer. The study findings will provide valuable insights into the safety and potential efficacy of ISA104, thereby contributing to the advancement of clinical programs aimed at improving patient outcomes.
ISA104 is the latest addition to ISA Pharmaceuticals’ pipeline programs and follows their lead program, ISA101b, which is currently in late-stage clinical development for the treatment of HPV16-induced cancers.
In conclusion, ISA Pharmaceuticals has initiated a groundbreaking Phase 1 study for the functional cure of chronic hepatitis B. This first-in-human trial aims to evaluate the safety, tolerability, and efficacy of ISA104, an immunotherapy developed using ISA’s Synthetic Long Peptide technology. The study, conducted in collaboration with the Erasmus Medical Center, will provide crucial information on the potential of ISA104 as a treatment option for patients with chronic hepatitis B virus infection.
