Dosing Completed in Phase 2a Trial of ANVS401
An additional 40 patients with Parkinson’s disease were treated with ANVS401, with the company now preparing to share final safety and efficacy data later this year.
According to a press release, Annovis Bio expects to submit all data to the U.S. Food and Drug Administration (FDA) prior to an end-of-phase meeting to determine the safety of proceeding to a Phase 3 clinical trial in Alzheimer’s and Parkinson’s diseases in the first quarter of 2022.
ANVS401, also known as Posiphen, is a small molecule that works by halting the production of certain proteins that can form toxic aggregates known to lead to the death of brain nerve cells such as alpha-synuclein in Parkinson’s and beta-amyloid and tau in Alzheimer’s. It does so by interfering with translation — the process by which proteins are made in cells.
ANVS401’s safety and efficacy are being evaluated in a two-part Phase 2a clinical trial (NCT04524351). In the first part, 14 patients with Alzheimer’s disease and 14 patients with Parkinson’s disease were selected randomly to receive either 80 mg of ANVS401 or a placebo once daily for 25 days.
Interim data from the first 14 patients with Parkinson’s disease — nine of whom received ANVS401 — revealed the therapy was safe and acted on a series of steps of the toxic cascade that leads to disease. It reduced the levels of alpha-synuclein itself, improved the health of nerve cells, and reduced the levels of certain inflammatory molecules in the brain. It also improved patients’ speed and coordination.
In the second part of the trial, 40 patients with Parkinson’s disease now received different doses of ANVS401 — 5, 10, 20, or 40 mg of ANVS401 once daily — for an extensive dose response study. Patients underwent blood and cerebrospinal fluid testing, cognitive assessments, clinical examinations, and laboratory safety testing.
“We closed the study and expect to have final safety and efficacy data to share in the fall and expect to finish analyzing the markers of the toxic cascade in approximately two to three months,” said Maria Maccecchini, PhD, founder, CEO and president of Annovis Bio.
“When we complete our analyses, we plan to summarize our data with our chronic toxicology results in animals and submit it to the FDA ahead of an end-of-Phase 2 meeting. We also look forward to discussing Phase 3 studies in AD and PD with the FDA with the goal of beginning Phase 3 in Q1 2022,” Maccecchini said.