AmyriAD Therapeutics a late clinical-stage pharmaceutical development company focused on advancing therapies for Alzheimer’s disease (AD), is developing AD101, a small synthetic molecule that modulates calcium channels to promote the release of acetylcholine, a neurotransmitter, in the brain. Data from several clinical trials showed that AD101 is well tolerated and suitable for once-daily oral administration. In randomised, double-blind and placebo-controlled clinical trials, AD101 was administered as an add-on to stable donepezil therapy. Adverse events or safety of tolerability did not change when AD101 was added onto treatment with donepezil, as compared to donepezil alone. Furthemore, a randomised, double-blind and placebo-controlled Phase II study of AD101 added on to a stable dose of 10mg/day donepezil demonstrated statistically significant additive improvement over that of donepezil alone in tests of global function and cognition.
The company is planning to launch a Phase III clinical trial program with AD101 in people with mild to severe AD. The first trial is planned to start in Q3 2024 in US and the second trial in Q1 2025 in Europe and Southeast Asia. These two 24-week, randomised, double-blind and placebo-controlled trials will be designed as adequate and well-controlled studies for safety and efficacy that will enrol 500 participants each. A group of participants will receive a single dose of the AD101/donepezil combination treatment while the other group will be given a placebo/ donepezil combination. According to the company, the Phase III endpoints must demonstrate that the drug improves cognition and global function, using the ADAS-Cog and AGS-CGIC tests. Once participation is completed in both trials, an open label Phase III extension study will be pursued to characterise long term safety and efficacy of the treatment.
