Clene presents VISIONARY-MS long term extension study results

Clene presented the Phase 2 VISIONARY-MS long term extension, or LTE, study results at the 2024 American Academy of Neurology, or AAN, annual meeting in Denver. Michael Barnett from the University of Sydney presented data demonstrating improved clinical, functional, and structural outcomes associated with daily oral dosing of CNM-Au8 30 mg for up to three years of treatment. These new long-term results from the Phase 2 VISIONARY-MS clinical trial demonstrated evidence supporting repair and remyelinating effects of CNM-Au8 treatment in patients originally randomized to CNM-Au8. The long-term results further enhance the trial’s findings from the double-blind period, which demonstrated significant improvements on low contrast letter acuity and on the modified MS Functional Rating Scale, the study’s primary and secondary endpoints, with continued improvement observed in the LTE. The significant and concordant results across multiple paraclinical exploratory endpoints reinforce the evidence for sustained clinical benefit to study participants across multiple clinical outcome measures, associated with consistent improvements in neuronal function and remyelination. Participants originally randomized to CNM-Au8 treatment experienced continued significant improvement in vision as measured by low contrast letter acuity. More than half of participants improved by 10 or more letters on a low-contrast Sloan eye chart, with increases of up to 38 letters. Participants originally randomized to placebo who transitioned to CNM-Au8 after the 48-week double blind period into the open label extension also experienced significant improvement in vision as measured by low contrast letter acuity following treatment with 30 mg CNM-Au8. Study participants treated with CNM-Au8 experienced up to 29 points of significant improvement in cognition and working memory as measured by the Symbol Digit Modality Test. Study participants treated with CNM-Au8 experienced significant improvements in both amplitude and latency as measured by multi-focal visual evoked potentials, physiologic measures of signal strength and speed along the visual pathway, markers of neuronal health and remyelination, respectively. MRI measures of axial diffusivity showed significant improvements in T2 brain lesions in study participants treated with CNM-Au8. MRI measures of T2 lesion myelin water fraction and magnetization transfer ratio, markers of remyelination, improved with long-term CNM-Au8 treatment. CNM-Au8 was well-tolerated, and no significant safety findings were observed.