Annovis Bio has started dosing patients in the Phase IIa clinical trial of ANVS401 for the treatment of early Alzheimer’s disease (AD) and Parkinson’s disease (PD).
In preclinical studies for AD and PD, ANVS401 was found to normalise axonal transport by blocking the neurotoxic proteins that destroy nerve cells.
Human and animal studies showed that the drug candidate lowers APP/Aβ, tau/phospho-tau, and α-synuclein, which are neurotoxic proteins involved in impairment of axonal transport, inflammation and cell death.
The candidate demonstrated promising tolerability profile in three Phase I trials.
During the two-part Phase IIa trial, a total of total of 28 AD and PD patients will receive ANVS401 for four weeks at various sites across the US.
The trial will monitor how nerve cells die in both patient populations 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 trial will also assess safety, tolerability and the effect of ANVS401 on motor impairment and non-motor symptoms in early PD patients, and on memory and cognitive function in early AD patients.
Initial results from this trial are expected early next year. After this year, a dose response study in 40 PD patients will be conducted and final data readout is anticipated next year.
Annovis Bio CEO Maria Maccecchini said: “This brings us one step closer to evaluating whether our approach may translate into a novel treatment option for patients suffering from a range of neurodegenerative diseases.
“While Covid-19 has previously delayed trials for most biopharma companies, including the start of this trial, having a diverse mix of study sites should afford us the opportunity to maintain recruitment and treatment schedules moving forward.”
Annovis Bio secured approval from the Central Institutional Review Board (IRB) in July this year to conduct the Phase II trial at 15 sites in the US.