Clene reports CNM-Au8 improves brain NAD+/NADH ratio in MS patients at ECTRIMS 2025; FDA open to cognition endpoints

Clene Inc.

Mean brain NAD+/NADH ratio increased +0.449 units (p=0.0148) across full REPAIR population (n=39) after 12 weeks of CNM-Au8.
In REPAIR-MS participants (n=26), NAD+/NADH ratio increased +0.480 units (p=0.058; percent change +9.49%, p=0.0275).
Baseline EDSS was significantly associated with NAD+/NADH ratio deficit (ρ=0.429, p=0.0127).
Baseline working memory (SDMT) and upper extremity function (9-HPT) correlated with brain ATP levels (p=0.0009, p=0.0032).
FDA acknowledged EDSS limitations and expressed openness to broader primary endpoints, including cognition, for MS trials.

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