Clene (NASDAQ:CLNN) said new data from a phase 2 trial in multiple sclerosis (MS) showed that CNM-Au8 treatment improved brain neuronal structural integrity.
The company reported updated MRI results from the phase 2 trial called VISIONARY-MS, 48-week treatment period in patients with MS.
The company said these exploratory MRI results support a previously reported statistically significant clinical improvements in low contrast vision and global neurological function in stable relapsing patients with MS reported in the mITT population.
The trial evaluated CNM-Au8 (15 mg or 30 mg daily) versus placebo in stable relapsing patients with MS with chronic optic neuropathy. Nearly all participants (92%) were treated with highly effective disease modifying therapies (DMT) as background standard of care, according to the company.
The company said that MRI findings provide proof of brain neuronal structural integrity that showed statistically significant results for key metrics of axonal integrity.
"These MRI data show clear overall improvements in measures of brain white matter integrity. Placebo treated patients had deterioration during the 48-week treatment period, while patients treated with CNM-Au8 had preserved white matter integrity," said Michael Barnett, one of the trial's clinical advisors.
Clene noted that CNM-Au8 is an oral suspension of gold nanocrystals developed to restore neuronal health and function by increasing energy production and utilization.
CLNN +44.44% to $1.95 premarket Feb. 13