The Center for Drug Evaluation (CDE) website has indicated that Huahui Health’s HH-003, Boehringer Ingelheim’s BI655130, Otsuka Pharma’s VIS649, and Eli Lilly’s Remternetug are on track to obtain priority review statues. These drugs target chronic hepatitis D virus (HDV), prevention of generalized pustular psoriasis (GPP), IgA nephropathy, and early Alzheimer’s disease (AD), respectively.
HH-003: A Potential Cure for Chronic Hepatitis B and HDV
HH-003, an in-house developed monoclonal antibody (mAb) by Huahui Health, is expected to functionally cure chronic hepatitis B virus (HBV) and HDV. It has shown an effective antiviral response in patients undergoing immune clearance in a Phase Ib study involving chronic HBV patients.
BI655130: A New Hope for GPP Patients
BI655130 (spesolimab), a first-in-class mAb targeting IL-36R developed by Boehringer Ingelheim, has demonstrated significant improvement in skin symptoms for patients with GPP in previous studies. GPP is a rare and severe disease characterized by extensive rupture of blisters on the skin, which can lead to organ failure and even death.
VIS649: An APROIL mAb for IgA Nephropathy
VIS649 (sibeprenlimab), an A proliferation-inducing ligand (APRIL) mAb originated by Visterra, was acquired by Otsuka via a USD 430 million deal in 2018. This acquisition included VIS649 alongside other kidney disease drug candidates, positioning it as a potential treatment for IgA nephropathy.
Remternetug: Targeting Early Alzheimer’s Disease
Remternetug (LY3372993), an N3pG-A β Amyloid protein antibody developed by Eli Lilly, has shown the ability to clear amyloid protein and deep plaques with good safety in early studies. Eli Lilly initiated the Phase III TRAILRUNNER-ALZ1 study in August 2022 to assess the efficacy and safety of the drug in early AD patients, with the primary endpoint being the percentage of patients with amyloid plaques cleared at the end of treatment. The study, conducted in the US and Japan, is expected to conclude in 2025.-Fineline Info & Tech
