Clene's Nanotherapeutic Improves Energy Production, Brain Utilization In Parkinson's, MS
- Clene Inc CLNN 3.18% has shared positive top-line results from the Phase 2 REPAIR trials investigating the improvement of brain energetic metabolism in Parkinson's disease (PD) and multiple sclerosis (MS).
- The objective of the REPAIR program was to demonstrate the effects of Clene's nanotherapeutic, CNM-Au8, on brain energy metabolites in two studies of patients with Parkinson's disease (REPAIR-PD) and multiple sclerosis (REPAIR-MS).
- Patients were imaged before and after 12 or more weeks of daily oral dosing with CNM-Au8.
- The results for the primary endpoint, the mean change in the brain NAD+/NADH ratio (the ratio of the oxidized to a reduced form of nicotinamide adenine dinucleotide), demonstrated a statistically significant increase by an average of 0.589 units (10.4%).
- The individual results for these sister studies demonstrated consistent statistical trends toward improvement in the NAD+/NADH ratio.
- CNM-Au8 treatment was well tolerated, with all treatment-emergent adverse events reported as predominantly mild and unrelated to the study drug.
- There were no serious adverse events or treatment discontinuations related to adverse events in either study.
- The clinical endpoint of MDS-UPDRS in REPAIR-PD showed no worsening of clinical status across the study population.
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