Our 100 Series lead compound, AD101, demonstrated statistically significant improvement in both core symptoms of AD in a placebo-controlled, double-blind, Phase 2 Proof-of-Concept Trial. Positive effects were accompanied by a profile of safety and tolerability that was not distinguishable from that of the placebo-treated cohort.
100 SERIES – SELECTIVE CaV3.1 AND CaV3.3 T-TYPE
CALCIUM CHANNEL MODULATOR
AD101 PHASE 2 DATA AND NEXT STEPS
Across 7 clinical trials, AD101 has been administered to over 500 subjects. Data from these trials demonstrated that AD101 is well tolerated and suitable for once-daily oral administration. Adverse events or safety of tolerability did not change when AD101 was added onto treatment with donepezil (Aricept®), the current global standard of care for AD since 1996, as compared to donepezil alone.
Furthermore, a randomized, double-blind, placebo-controlled Phase 2 study of AD101 added on to a stable dose of 10mg/day donepezil demonstrated statistically significant additive improvement in global function and cognition compared with donepezil alone.
AMYRIAD is planning three Phase 3 trials, two adequate and well-controlled (AWC) trials for efficacy and safety, plus and open-label extension study of long-term safety and tolerability. The first will be a US-based, 24-week, randomized, double-blind, placebo-controlled trial for patients with mild through severe AD. The second is planned to be a worldwide study.