In mid-August 2021, Parkinson’s News Today reported that dosing was complete in a Phase 2a clinical trial. During the trial, researchers were evaluated ANVS401, an investigational compound for patients with Alzheimer’s disease (AD), Alzheimer’s disease and dementia in Down syndrome (AD-DS), and Parkinson’s disease (PD). In this particular trial, the research centered around ANVS401 for patients with AD and PD in particular. While initial interim data has been released, the full trial data should be available before the end of 2021.
ANVS401
According to drug developer Annovis Bio (“Annovis”), ANVS401 is:
being developed for AD, AD-DS and PD, because in preclinical studies it improved axonal transport in these diseases by inhibiting the neurotoxic proteins that kill nerve cells. It was shown in human and animal studies to lower APP/A, tau/phospho-tau, and -synuclein, the neurotoxic proteins that impair axonal transport and lead to inflammation and cell death.
In prior studies, ANVS401 was shown to be relatively safe and well-tolerated. The treatment, which also showed efficacy, worked quickly. Prior studies highlighted how ANVS401 treatment could improve cognition, short-term memory, visual-motor dexterity, and nonverbal learning by up to 30%.
Most recently, dosing finished in a Phase 2a clinical trial. In the first portion of the trial, 28 patients (half with PD and half with AD) received either a placebo or 80mg ANVS401 daily for a 25-day period. In the interim data released, ANVS401 lowered alpha-synuclein (a-synuclein) levels, improved nerve cell health, and reduced inflammatory substances. Additionally, treatment helped patients regain speed and coordination. Thus, researchers determined that ANVS401 stopped the protein cascade which causes PD at the source.
40 patients with PD were dosed in the most recent portion of the trial. During this portion, patients received a variety of doses (5mg, 10mg, 20mg, or 40mg). Ultimately, researchers hope to understand the efficacy of the different doses or how these might stop the toxic cascade leading to AD and PD. Researchers hope to release the data later this year, as well as move onto future Phase 3 trials in 2022.
Alzheimer’s disease (AD)
Alzheimer’s disease (AD) is a progressive neurodegenerative disorder which increases in severity over time. Doctors believe that a blend of genetics, environmental factors, and lifestyle factors play a role in AD development. Regardless, the condition occurs when neurons in the brain disconnect and die. Proteins called plaques and tangles may also play a role. As these neurons die, patients experience increased difficulty regarding memory, judgments, planning, and preserved skills. Additionally, many patients often experience changes in mood, personality, or behavior. Risk factors, outside of those listed, include age (65+), a family history of AD, being female, prior head trauma, and poor sleeping or exercise patterns.
Parkinson’s disease (PD)
Parkinson’s disease (PD) is a progressive central nervous system (CNS) disorder which impacts movement. Altogether, PD occurs in five stages; in the earliest stage, patients experience only light tremors on one side of the body. However, by the middle stages, patients often experience slowed movement and balance difficulties, and may be unable to live independently. By the final stage of PD, patients may experience delusions, and have difficulty standing or walking. PD occurs when dopaminergic neurons die, causing abnormal brain activity. The presence of Lewy bodies, as well as genetics and environmental factors, are believed to play a role. PD symptoms include muscle rigidity, tremors, slurred speech, slowed movement, impaired posture and balance, and neuropsychiatric difficulties.
