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Oral ANVS401 improves motor skills in patients in phase 2 trial – Parkinson’s News Today

In a phase 2a clinical trial, once-daily treatment with ANVS401 by mouth was found to significantly improve motor skills in patients with Parkinson’s disease.

Annovis Bio, the company developing ANVS401, now plans to meet with the US Food and Drug Administration (FDA) to discuss the possibility of initiating larger Phase 3 studies.

“We are delighted with these improvements in the motor function of the PM [Parkinson’s disease] patients,” said Maria Maccecchini, PhD, Founder, President and CEO of Annovis, in a press release.

“We will be requesting a meeting from the FDA to receive guidance on next steps in clinical development in light of … Phase 2 clinical results,” she added.

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ANVS401, also known as posiphene, 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 disease and other neurological diseases.

The phase 2 clinical trial (NCT04524351), opened last year, was conducted in two parts. In the first, 14 people with early Parkinson’s disease and 14 people with early Alzheimer’s disease were randomly assigned to 80 mg of ANVS401 or a placebo once daily for 25 days. The intermediate data was positive; treatment with ANVS401 was associated with stabilization or improvement in speed and coordination.

In the second part of the study, 40 additional adults in the early stages of Parkinson’s disease were recruited. These participants received either a placebo or ANVS401 at 5, 10, 20, 40 or 80 mg once daily for 25 days.

The results were then analyzed for the 54 patients with Parkinson’s disease who participated in both parts of the trial.

The drug’s effectiveness was measured based on scores from the Wechsler Adult Intelligence Scale (WAIS) coding test, a measure of cognitive abilities in adults, and the MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), a specific measure of Parkinson’s disease. gravity.

Compared to patients on the placebo capsule, those who received ANVS401 at doses of 5, 20 or 80 mg showed significant improvements on WAIS scores. Additionally, these patients’ WAIS scores were significantly higher at the end of the study (25 days) than they were at the start (baseline measures).

Specific improvements in the WAIS score indicated better motor dexterity, as well as greater speed and accuracy in performing the assessment.

Significant gains from baseline were also recorded in patients who received ANVS40 10 or 20 mg on the global MDS-UPDRS score, as well as on several subscales of this global measure.

These results, taken together, indicate that the treatment was effective at the doses tested, suggesting that the highest efficacy can be seen at doses around 10 or 20 mg per day, Annovis said.

“Through examining this dose-response, we can determine a safe and effective optimal dose as we move towards initiating Phase 3 clinical trials with much larger patient populations and longer timelines,” Maccecchini said.

“These positive efficacy results, which build on our previous data from AD [Alzheimer’s disease] and patients with PD, clarifies the benefits that ANVS401 may offer patients suffering from these chronic neurodegenerative diseases,” she added.

Maccecchini noted that additional trial data, such as the effect of treatment on biological markers of disease activity, are still being analyzed and will be presented at a later date.

Earlier interim trial data also confirmed the safety of treatment at a dose of 80 mg once daily.

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