skip to Main Content

Preclinically, our compounds produce significant and durable increases in synaptic density within several days. In patients, the emergence of new synapses should lead to measurable improvements in clinical symptoms. This synaptic-targeting mechanism should therefore allow clinical trial durations of three to six months and enrollment of patients across a broad range of disease severities.

We completed a successful Phase 1 study in June 2019. Our lead compound, RDN-929, was found to be safe and well-tolerated at all dosage levels, with favorable pharmacokinetic and pharmacodynamic properties. We will soon move into a Phase 1b study in patients. This trial will continue to assess safety, tolerability and PK over a longer dosing period, as well as exploratory measures including fluid and neuroimaging biomarkers measuring synaptic density.

Phase 1b data will help inform our plans for conducting multiple Phase 2 trials in synaptopathies with high unmet need. Each Phase 2 trial will enroll well-characterized patients who will be assessed via multiple outcomes: cognition, function, behavior, neuroimaging, digital endpoints and fluid biomarkers.