The trial is designed to evaluate the safety and tolerability of GIGA-2339 in individuals with confirmed chronic HBV infection. Credit: NTshutterth/Shutterstock.

GigaGen, a subsidiary of Grifols, has commenced a Phase I dose escalation trial, with the first patient receiving a dose of GIGA-2339, a recombinant polyclonal drug candidate aimed at treating hepatitis B virus (HBV) infection.

This trial is designed to evaluate the safety and tolerability of the drug in individuals with confirmed chronic HBV infection.

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As part of Grifols’ commitment to innovation and the development of advanced antibody medications, GIGA-2339 has been created using GigaGen’s advanced platform.

The drug is composed of over 1,000 anti-HBV antibodies, which have been engineered in a lab to mimic the natural antibody response of donors vaccinated against HBV.

Its potency is claimed to be more than 2,000 times greater than that of plasma-derived HBV treatments, and encompasses a broad spectrum of HBV variants.

Preclinical studies in mouse models have demonstrated that GIGA-2339 can neutralise and eliminate HBV’s viral antigens and deoxyribonucleic acid (DNA).

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This distinct mechanism could potentially clear viral particles and stimulate the immune system, offering a functional cure for individuals living with HBV.

GigaGen head and Grifols senior vice-president Carter Keller said: “The initiation of this Phase I trial with GIGA-2339 represents a milestone in our mission to develop the next generation of antibody drugs for addressing infectious disease treatment.

“By harnessing the precision of these antibodies, it targets the large diversity of circulating HBV variants, offering a more targeted and effective solution with potential to bring new hope to millions affected by this chronic disease.”

In May this year, the company dosed the first subject in a Phase I trial of GIGA-564 targeting metastatic or locally advanced solid tumours.

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