GIGA-2339 for Hepatitis B

This trial aims to test the safety of a new treatment, GIGA-2339, for individuals with chronic Hepatitis B. It consists of two parts: one testing a single dose and another testing multiple doses over time. Participants will receive either the treatment or a placebo (a harmless, inactive substance). Suitable candidates have had Hepatitis B for at least 6 months, are currently on stable medication, and can continue this medication throughout the study. As a Phase 1 trial, participants will be among the first to receive this new treatment, assisting researchers in understanding its effects in people.

You will need to stay on your current stable dose of nucleot(s)ide analogues (a type of medication for Hepatitis B) while participating in the study.

Research has shown that GIGA-2339 is undergoing safety testing in people with chronic Hepatitis B. This treatment is in the early stages, focusing mainly on its safety for humans. Before human testing, studies demonstrated that GIGA-2339 could reduce a key protein linked to the virus. This early testing is crucial for identifying any side effects or risks.

Most treatments for Hepatitis B, like antivirals such as tenofovir or entecavir, work by suppressing the virus. But GIGA-2339 stands out because it targets the virus with a new mechanism of action, potentially reducing the virus more effectively. Researchers are excited because this treatment is administered through an intravenous infusion, which may allow for more controlled and potent dosing compared to oral medications. Additionally, the ability to use both single and multiple ascending doses means there's a chance to fine-tune the treatment to maximize its benefits while minimizing side effects.

Research has shown that GIGA-2339 is highly effective against Hepatitis B, being over 2,000 times stronger than some current treatments. Early studies indicate that it can significantly reduce levels of HBV surface antigens, which signal infection. The trial will evaluate GIGA-2339 in two parts: Part 1 involves a Single Ascending Dose (SAD) where participants receive a single IV infusion of either GIGA-2339 or a placebo, and Part 2 involves a Multiple Ascending Dose (MAD) with multiple IV infusions. This suggests that GIGA-2339 might effectively target different virus types. Its unique combination of antibodies could also enhance the immune system's ability to fight the infection. While these results are promising, further research is needed to confirm these effects in people.¹²³⁵⁶