A planned Phase 2 clinical trial evaluating ANVS401, Annovis Bio‘s lead investigational therapy for people in the early stages of Alzheimer’s and Parkinson’s disease, has received approval from a central institutional review board (IRB).
An IRB is an administrative body responsible for protecting the rights and welfare of human research subjects participating in clinical trials. Among its duties, the IRB reviews a trial’s proposed design and purpose to ensure they are up to ethical standards.
“We are excited to receive IRB approval to move forward with this Phase 2 study in PD [Parkinson’s disease] and AD [Alzheimer’s disease],” Maria Maccecchini, PhD, the CEO of Annovis Bio, said in a press release. “We believe we remain on track to complete the study by the first quarter of 2021.”
Both Parkinson’s and Alzheimer’s are characterized by the pathological buildup of clumps of proteins in the brain — specifically, clumps of the protein alpha-synuclein in Parkinson’s, and of beta-amyloid and tau in Alzheimer’s. These accumulations disrupt communication between nerve cells and eventually leads to cell death.
ANVS401, also known as Posiphen, is an oral small molecule that prevents the production of these protein aggregates by interfering with their translation — the process through which a protein is made from a messenger RNA template by ribosomes, the cell’s protein-making machinery. In doing so, it is expected that ANVS401 will lower the levels of toxic proteins and improve transport within neurons (axonal transport). It was recently patented by Annovis.
Previous studies using cells in dishes and animal models of both Alzheimer’s and Parkinson’s have supported the treatment’s efficacy — for instance, ANVS401 was shown to lessen gut problems thought connected to alpha-synuclein buildup in mouse models of Parkinson’s.
The upcoming clinical trial plans to enroll a total of 68 people with Alzheimer’s or Parkinson’s at 15 sites across the U.S. Participants will be treated with ANVS401 for four weeks.
Trial researchers will evaluate the steps in the toxic cascade that lead to neuron death in both conditions, and assess how ANVS401 affects this cascade. In other words, the study will determine whether ANVS401 can lessen the accumulation of toxic proteins, and whether the reduction achieved leads to improvements in neuronal health and brain function.
This Phase 2 study will also assess the safety and tolerability of the investigational medication, as well as its effect on symptoms — including motor impairment and non-motor symptoms in Parkinson’s patients, and memory and cognitive problems in those with Alzheimer’s, the release stated.
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