The study will assess the safety, tolerability and efficacy of ISA104 in chronic HBV patients. Credit: Jarun Ontakrai / Shutterstock.

Dutch biotechnology company ISA Pharmaceuticals has dosed the first patient in its first-in-human (FIH) Phase I HEB-PEP study of ISA104.

The HEB-PEP dose-escalation study will evaluate ISA104, a new treatment designed to establish a functional cure for chronic hepatitis B (HBV) patients.

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The trial’s first patient was dosed at the Liver Unit of the Erasmus Medical Center in Rotterdam, Netherlands, which sponsored this study.

ISA Pharmaceuticals chief medical officer Leon Hooftman said: “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.”

The study will assess the safety, efficacy and tolerability of different ISA104 doses in chronic HBV patients against a placebo.

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It is being carried out in partnership with researchers from the Gastroenterology & Hepatology department at Erasmus MC in Rotterdam.

ISA developed the ISA104 immunotherapy in partnership with Erasmus MC using its Synthetic Long Peptide (SLP) technology.

Erasmus MC department of gastroenterology and hepatology principal investigators Drs Sonja Buschow and Dave Sprengers said: “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.”