Biotech company Annovis Bio has revealed positive results for its lead investigational therapeutic ANVS401 in Alzheimer’s disease (AD) and Parkinson’s disease (PD).
The results come from a small phase 2a study evaluating ANVS401 in 14 AD patients and 14 PD patients.
The results show that patients treated with ANVS401 for 25 days achieved statistically significant cognitive improvement, measured by the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11).
Specifically, patients in the ANVS401-treated group saw their ADAS-Cog11 scores improve by 4.4 points from baseline until 25 days – an improvement of 30%.
The ANVS401 treatment group also showed an improvement of 3.3 points (22%) compared to placebo at 25 days.
Biogen’s aducanumab, in comparison, showed a 1.4 point improvement in ADAS-Cog13 over 18 months, while a phase 2 study of Cassava’s simufilam demonstrated a 1.6 point improvement on ADAS-Cog11 after six months.
“The results from the first cohort of 14 AD and 14 PD patients show that the drug is effective in both diseases. Seeing efficacy in both patient populations supports our hypothesis that the impairment of axonal transport, the information highway of the nerve cell, affects nerve cells in the same way in both diseases,” said Maria Maccecchini, chief executive officer of Annovis Bio.
“The toxic cascade in neurodegeneration begins with high levels of neurotoxic proteins, which impair axonal transport, increase inflammation and eventually lead to nerve cell death and permanent loss of cognition and function,” she added.
ANVS401 is designed to inhibit the translation of multiple neurotoxic proteins – high levels of neurotoxic proteins result in impaired axonal transport, which plays a key role in the communication between and within nerve cells.
Through this inhibition, ANVS401 can improve axonal transport, reduce inflammation, protects nerve cell death and improve cognition and function, Annovis said in a statement.
Annovis is continuing to analyse the cerebral spine fluid and plasma samples of the first 28 patients from the phase 2a study, with the aim of measuring the reversal of the toxic cascade.
Additional data is expected to be revealed in the next two months, the company added, with full study data anticipated in July or August 2021.
When the phase 2a study is completed, Annovis said it will request a meeting with the US Food and Drug Administration (FDA) to present the results, along with its chronic toxicology study in animals.