Zervimesine for geographic atrophy secondary to dry age-related macular degeneration
phase 2drug program · high · Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Assess whether orally delivered CT1812 can treat geographic atrophy associated with dry age-related macular degeneration.
Phase 2 prospective, multicenter, randomized, double-masked, placebo-controlled 104-week study comparing oral CT1812 with placebo.
Public record for the Phase 2 geographic atrophy study was published on 2023-06-16.
Zervimesine for dementia with Lewy bodies
phase 2drug program · high · Thu May 19 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Evaluate safety, tolerability, and efficacy of zervimesine in mild to moderate dementia with Lewy bodies.
Multi-center, randomized, double-blind, placebo-controlled 6-month clinical study of oral CT1812 in participants with mild to moderate dementia with Lewy bodies.
Public record for a dementia with Lewy bodies clinical trial was published on 2022-05-19.
Zervimesine clinical pharmacology program
phase 1research program · medium · Tue Feb 15 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Characterize CT1812 dosing, pharmacokinetics, absorption, metabolism, excretion, mass balance, and drug-drug interaction profile in healthy volunteers.
Ascending-dose healthy volunteer study, older healthy volunteer pharmacokinetic study, open-label single-dose C14 mass-balance study, and open-label drug-drug interaction study using probe drugs.
An older healthy volunteer pharmacokinetic study public record was published on 2022-02-15; mass-balance and drug-interaction studies were also listed in public records.
Zervimesine for Alzheimer's disease
phase 2drug program · high
Evaluate zervimesine as an oral therapy for Alzheimer's disease by protecting synapses and preventing or displacing amyloid beta oligomer binding at neuronal synapses.
Once-daily brain-penetrant small-molecule oral therapy targeting sigma-2 receptor/S2R-TMEM97; evaluated in randomized, double-blind, placebo-controlled Phase 2 Alzheimer's disease trials and earlier Phase 1b/Phase 2 mechanistic studies.
A Phase 2 early Alzheimer's disease study was listed in public records, and SHINE Phase 2 biomarker analyses were reported in a 2026 publication.
In SHINE, zervimesine was reported to slow cognitive decline by 38% in the modified intent-to-treat population and by 95% in a pre-specified low p-tau217 subgroup; exploratory biomarkers showed decreased GFAP and trends toward decreased NfL, Aβ42, and Aβ40 in the low p-tau217 subgroup.
Zervimesine plasma biomarker and proteomics program
exploratorybiomarker · high
Identify pharmacodynamic biomarkers and enrichment strategies for zervimesine response in Alzheimer's disease, including lower baseline p-tau217 and neuroinflammatory or proteomic markers.
Exploratory plasma biomarker analyses from the SHINE Phase 2 trial using targeted assays for Aβ40, Aβ42, GFAP, NfL, and BD-tau, plus untargeted TMT mass-spectrometry proteomics with pathway and correlation analyses.
A 2026 Alzheimer's Research & Therapy publication reported SHINE plasma biomarker and proteomic findings.
Findings were stronger in the low p-tau217 subgroup; GFAP significantly decreased with zervimesine versus placebo, while NfL, Aβ42, and Aβ40 trended downward. Proteomics suggested effects on amyloid biology, trafficking, lipid metabolism, and immune response.
