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Once-a-day treatment with oral ANVS401 was found to significantly improve motor skills among Parkinson’s disease patients in a Phase 2a clinical trial.
Annovis Bio, the company developing ANVS401, is now planning to meet with the U.S. Food and Drug Administration (FDA) to discuss possibly initiating larger Phase 3 studies.
“We are thrilled by these improvements in motor function of PD [Parkinson’s disease] patients,” Maria Maccecchini, PhD, the founder, president, and CEO of Annovis, said in a press release.
“We will be asking the FDA for a meeting to receive guidance on next steps in clinical development in light of the … Phase 2 clinical results,” she added.
ANVS401, also known as posiphen, is an oral small molecule designed to block the production of proteins that form toxic aggregates in the brain. Abnormal protein aggregates are thought to drive the progression of Parkinson’s and other neurological diseases.
The Phase 2 clinical trial (NCT04524351), which opened last year, was conducted in two parts. In the first, 14 people with early Parkinson’s and 14 with early Alzheimer’s were randomly assigned to either 80 mg of ANVS401 or a placebo once daily for 25 days. Interim data were positive; treatment with ANVS401 was associated with stabilization or improvement in speed and coordination.
In the study’s second part, an additional 40 adults in the early stages of Parkinson’s were recruited. These participants were given either a placebo or ANVS401 at 5, 10, 20, 40, or 80 mg once daily for 25 days.
Results were then analyzed for all 54 Parkinson’s patients who participated across both parts of the trial.
The medication’s efficacy was measured based on scores of the Wechsler Adult Intelligence Scale coding test (WAIS), a measure of cognitive abilities in adults, and the MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), a disease-specific measure of Parkinson’s severity.
Compared to patients on a placebo capsule, those given ANVS401 at doses of 5, 20, or 80 mg showed significant improvements on WAIS scores. Additionally, WAIS scores in these patients were significantly higher at the study’s end (25 days) than they had been at its start (baseline measures).
Specific WAIS score improvements indicated better motor dexterity, and more speed and accuracy in completing the assessment.
Significant gains from baseline were also recorded among patients given ANVS40 at 10 or 20 mg on the MDS-UPDRS overall score, as well as on several subscales of this comprehensive measure.
These results, overall, indicate that the treatment was effective at the doses tested, hinting that the highest efficacy may be seen at doses of around 10 or 20 mg a day, Annovis stated.
“Through examination of this dose-response, we can determine an optimal safe and efficacious dose as we move forward towards initiation of Phase 3 clinical trials with much larger patient populations and longer timelines,” Maccecchini said.
“These positive efficacy results, which expand on our previous data from AD [Alzheimer’s disease] and PD patients, add clarity to the benefits that ANVS401 may offer to patients suffering from these chronic neurodegenerative diseases,” she added.
Maccecchini noted that additional trial data, such as the treatment’s effect on biological markers of disease activity, are still being analyzed, and will be presented at a later date.
Earlier interim trial data also supported the treatment’s safety at a dose of 80 mg once a day.'
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