Drug platform company Annovis Bio has secured approval from the Central Institutional Review Board (IRB) to conduct a Phase II clinical trial of ANVS401 at 15 sites in the US.
The study will enrol 68 patients with early Parkinson’s disease or Alzheimer’s disease.
ANVS401 is the company’s lead compound. In preclinical studies, the drug candidate was able to normalise axonal transport in these diseases via the inhibition of the neurotoxic proteins that kill nerve cells.
In human and animal studies, ANVS401 lowered APP/Aβ, tau/phospho-tau, and α-synuclein, the neurotoxic proteins that impair axonal transport, which causes inflammation and cell death.
The candidate demonstrated favourable tolerability profile in three Phase I trials.
During the two-part Phase II trial, participants will receive ANVS401 for four weeks.
The trial will monitor how nerve cells die by measuring all the toxic cascade steps resulting in nerve cell death and how the drug candidate might reverse the toxic cascade and restore normal brain function.
The study will also assess safety, tolerability and the effect of ANVS401 on motor impairment and non-motor symptoms in early Parkinson’s patients and on memory and cognitive function in early Alzheimer’s patients.
Annovis Bio CEO Maria Maccecchini said: “We are excited to receive IRB approval to move forward with this Phase II study in PD and AD.
“While the original initiation of the trial was delayed due to Covid-19, we believe we remain on track to complete the study by the first quarter of 2021.”
Parkinson’s is known to impact around one million people in the US and ten million globally. An estimated 5.8 million people have Alzheimer’s in the US, with approximately 44 million people suffering from the disease worldwide.
In February this year, Annovis Bio announced plans to continue its Phase II DISCOVER trial of ANVS401 in patients with Alzheimer’s.