Two Alzheimer’s Organizations to Fund Phase 2 Trial of Amylyx Combo Therapy

Two Alzheimer’s Organizations to Fund Phase 2 Trial of Amylyx Combo Therapy
The Alzheimer’s Association and Alzheimer’s Drug Discovery Foundation will fund a Phase 2 clinical trial of a combination therapy that Amylyx Pharmaceuticals is developing for Alzheimer’s disease. Amylyx will receive $1.85 million for the trial of AMX0035, which consists of an oral formulation of sodium phenylbutyrate (PB) and tauroursodeoxycholic-acid (TUDCA). PB activates genes responsible for protecting brain cells from toxic unfolded proteins. The U.S. Food and Drug Administration has approved the compound for urea-cycle disorders, metabolic dysfunctions that make it hard for the body to break down proteins. TUDCA is an acid that the body produces in small quantities to prevent cell energy loss. In preclinical-trial studies, the combination therapy was shown to protect brain cells from inflammation and oxidation. Oxidation is the process by which the body converts food into energy. It can be harmful when it generates free radicals, which can damage the body. "Combination therapies hold great potential to slow the progression of Alzheimer's," Dr. Howard Fillit, the the drug discovery foundation's chief science officer, said in a press release. "The innovation of Amylyx's combination therapy is that it targets multiple causes of brain cell loss, and the two drugs given in tandem create additional protective effects. The foundation "was an early supporter of
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