First patient dosed in phase 1 study for chronic hepatitis B treatment
ISA Pharmaceuticals has announced that the first patient has been dosed in its phase 1 HEB-PEP study, assessing the use of ISA104 for the treatment of patients with chronic hepatitis B. This is a first-in-human trial assessing the novel treatment with the intention of finding a functional cure for this indication.
The study aims to assess the safety, tolerability and efficacy of different doses of the drug in chronic hepatitis B patients compared to placebo. ISA is conducting the trial in collaboration with investigators from the Gastroenterology and Hepatology department of the Erasmus MC in Rotterdam, the Netherlands.
Leon Hooftman, chief medical officer of ISA Pharmaceuticals, commented: “We are delighted to announce that the first patient has been dosed with ISA104 in the HEB-PEP clinical study, marking an important milestone in our mission to develop an effective treatment for patients with chronic hepatitis B virus infection, a tremendous global health burden and a defined cause of liver cancer. The study will provide crucial information on the safety and potential efficacy of ISA104, as we continue to advance our clinical programmes with a focus on improving patient outcomes.”
Dr Sonja Buschow and Dr Dave Sprengers, principal investigators on the trial from Erasmus MC’s department of Gastroenterology and Hepatology, added: “We are excited by the progress we are making in this first-in-human trial and eager to learn the potential impact that ISA104 based therapy could have on patients suffering from chronic hepatitis B virus infection. This study will allow us to determine how safety issues and immune responses in patients receiving ISA104 relate to those occurring by chance and to deepen our understanding of this promising new therapy, of HBV-directed immune responses and on novel HBV biomarkers”
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