New Medication for Hepatitis B Cure

New Medication for Hepatitis B Cure

In between few times before GigaGen invent a unique therapy for hepatitis b virus cure and doing research on that anti-viral medication therapy for hepatitis B patients, which is already given a green signals to launch in the market after completing it’s period shortly. The new therapy called GIGA-2339, is now set to enter phase 1 clinical trials by following a recent FDA approval of the company's investigational new drug application. This new therapy name is GIGA-2339 is developed by GigaGen, a Grifols Company.

GIGA-2339 is the first recombinant human polyclonal antibody treatment for HBV and the FDA approved this drug to begin trials in late 2024.

Carter Keller, the Senior VP at Grifols and Head of GigaGen. He said, there has been significant progress in the development of the first recombinant human polyclonal antibody therapies aimed at a functional cure for Hepatitis B virus (HBV). Keller stated, it consists of thousands of antibodies all directed towards the Hepatitis B virus. We call these types of therapies recombinant polyclonal antibody therapies, which are very unique. New Medication for Hepatitis B Cure.

He also said, what we find with our diverse antibody therapy is that it’s over 2000 times more potent than currently available therapies, as demonstrated in both in vitro and in vivo experiments. In pre-clinical studies, GIGA-2339 showed more than 2000 times the potency of current plasma-derived HBV treatments, suggesting it could effectively neutralize and clear the virus.

This unique therapy could potentially provide a functional cure for HBV and can be scaled efficiently in a lab setting. Keller outlined the objectives and endpoints, “For Phase-1 trials, the primary outcomes typically focus on safety and tolerability, while pharmacokinetics are secondary outcomes.

This is very exciting news about the upcoming trials really! Keller also said, we have both a single ascending dose and a multi-ascending dose study. The FDA has agreed that the right patient population for this study are those with chronic Hepatitis B infection. We will be exploring various endpoints, including markers of chronic infection, levels of the virus, and surface antigen levels to assess how potent we are in humans at different dose levels,” Keller explains.

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