CY6463 administration is linked to improvements in Alzheimer’s disease-relevant biomarkers, as revealed by eXplainable AI-driven analysis of multiple Phase 1 clinical trials ?

• Phase 1 studies show improvement in cognitive factors, consistent with therapeutic potential of CY6463 to improve key features in neurological diseases
• CY6463 favorable tolerability and safety profile was confirmed

Ariana Pharma, a leading Artificial Intelligence (AI) drug development company, in collaboration with Cyclerion Therapeutics, presented today safety and pharmacodynamic results from a post hoc analysis of CY6463 first-in-human studies at the 2022 Clinical Trials On Alzheimer’s Disease (CTAD) international conference held in San Francisco, USA.

Cyclerion Therapeutics’ CY6463 is a first-in-class, CNS-penetrant, soluble guanylate cyclase (sGC) stimulator that modulates a key node in a fundamental signaling pathway. CY6463 has been evaluated in two Phase 1 studies in healthy volunteers as well as signal-seeking patient studies in the rare mitochondrial disease, MELAS (mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes) and in CIAS (cognitive impairment associated with schizophrenia); a study in AD (Alzheimer’s disease) is ongoing. Cyclerion is advancing CY6463  for the treatment of rare mitochondrial diseases.

A total of 134 healthy participants were enrolled across two randomized, placebo-controlled, Phase 1 studies in which single-ascending doses, multiple-ascending doses, food effect (crossover design) and the pharmacology of CY6463 (crossover design) were evaluated. In each study, safety, pharmacokinetic, and endpoints assessments were collected at baseline and at the end of dosing. Previously reported favorable safety profile of CY6463 was confirmed, with no major adverse events.