Drug intelligence / Profile preview

ALF-5755

Development stage
Phase 2
Lead developer
The Healthy Aging Company
Modality
Recombinant Proteins and Enzymes, Small Molecules
Administration
Intravenous, Subcutaneous
01

Overview

ALF-5755 is a recombinant form of the human hepatocarcinoma-intestine-pancreas/pancreatic-associated protein (HIP/PAP), also known as REG3A. It is a C-type lectin with antioxidant and anti-inflammatory properties that modulates glucose and lipid homeostasis. The drug has been developed as a growth factor and neuroprotectant for the treatment of severe acute hepatitis (SAH), acute liver failure (ALF) not due to acetaminophen overdose, and type 2 diabetes mellitus (T2DM) with complications such as peripheral neuropathy. Mechanistically, ALF-5755 acts by binding to fibrin in inflamed tissue extracellular matrix where it exerts local anti-inflammatory and reactive oxygen species scavenger effects. This leads to reduced cellular necrosis, stimulation of liver cell proliferation/regeneration, restoration of insulin sensitivity via activation of insulin and glucose receptors in skeletal muscle, improved glucose uptake/utilization in muscle tissue through AMPK activation, decreased plasma triglycerides levels without affecting body weight or basal insulin levels[1][2][3][4][5][8]. The drug was well tolerated in phase 1 trials; phase 2 studies showed potential benefit particularly in subgroups with HBV/AIH-related severe SAH[2][7]. It has orphan drug status for liver failure.

Other names
Recombinant hepatocarcinoma-intestine-pancreas pancreatitis-associated proteinRecombinant HIP/PAPrhHIP/PAPREG3A protein humanREG-3A protein humanREG 3A protein human
02

Targets

Fibrin (Factor Ia)

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