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Abstract Details

VISIONARY-MS Long-Term Extension: A Multi-Centre, Open-Label Long-Term Extension Study of CNM-Au8 in Patients with Stable Relapsing Multiple Sclerosis
Multiple Sclerosis
ES2 - Emerging Science 2 (6:18 PM-6:24 PM)
009

CNM-Au8 is a neuroprotective investigational drug that catalytically enhances cellular metabolic energy. Results from the double-blind period demonstrated that CNM-Au8 treatment improved low contrast letter acuity (LCLA, 1° endpoint) and global neurological function assessed by the modified MS Functional Composite (2° endpoint) compared to placebo in stable RMS patients receiving approved disease-modifying immunomodulatory therapy (DMTs) as standard of care. Here we present analyses from the long-term open-label extension (LTE) study of participants from VISIONARY-MS LTE.

VISIONARY-MS LTE trial assessed the long-term safety, efficacy, tolerability, and pharmacokinetics of CNM-Au8 30mg on participants with stable relapsing MS (RMS) over 96 weeks following completion of the 48-week double-blind period.

The VISIONARY-LTE participants received daily doses of CNM-Au8 30mg. In addition to safety, functional endpoints were assessed at clinical visits every 12 weeks: LCLA for each eye by 2.5% Sloan letter chart, modified MSFC score that including the Timed 25-Foot Walk (T25FWT), Symbol Digit Modality Test (SDMT), 9-Hole Peg Test (9HPT, dominant and non-dominant hands), and LCLA (both eyes).

55 of 69 eligible participants (80%) originally randomized were eligible and participated in the LTE. The LS-mean difference (SE) at week 144 for: (i) LCLA change across both eyes vs. the original randomization baseline of participants assigned to CNM-Au8 was +8.7 letters (1.88), 95% CI: 5.0-12.4, p<0.0001 (ii) SDMT change vs. the original randomization baseline of participants assigned to CNM-Au8 was +8.03 (1.52), 95% CI: 5.01-11.0, p<0.0001. Improvements during the double-blind period were maintained in the LTE for T25FWT and 9PHT. Individual treatment responses showed consistent improvement with substantial gains in low contrast vision and cognition. Observed LCLA change from the end of the double-blind period ranged up to 38 letters across both eyes.

These results provide long-term evidence for sustained improvements in neurological functions in stable RMS patients treated with CNM-Au8 adjunctively to DMTs.

Authors/Disclosures
Michael Barnett, MBBS
PRESENTER
Dr. Barnett has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Clene Nanomedicine. Dr. Barnett has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Barnett has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Barnett has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Novartis. An immediate family member of Dr. Barnett has stock in Sydney Neuroimaging Analysis Centre. The institution of Dr. Barnett has received research support from BMS. Dr. Barnett has received personal compensation in the range of $500-$4,999 for serving as a Moderator/Speaker with Beamtree. Dr. Barnett has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Biogen. Dr. Barnett has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Roche. Dr. Barnett has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Novartis. Dr. Barnett has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Alexion.
Heidi N. Beadnall, MD (Sydney Neurology) Dr. Beadnall has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Beadnall has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Beadnall has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. The institution of Dr. Beadnall has received research support from MSBase Foundation.
No disclosure on file
Robert C. Sergott, MD (Wills Eye Hospital) Dr. Sergott has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Sergott has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon Therapeutics. Dr. Sergott has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen.
Benjamin M. Greenberg, MD, FAAN (UT Southwestern Medical Center) Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Greenberg has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Serono. Dr. Greenberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Horizon. Dr. Greenberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi/Genzyme. Dr. Greenberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech/ROche. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Signant. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for IQVIA. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bayer. Dr. Greenberg has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Clene. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cycle Pharma. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for IQVIA. Dr. Greenberg has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Siegel Rare Neuroimmune Association. Dr. Greenberg has stock in GenrAb. Dr. Greenberg has stock in Clene. The institution of Dr. Greenberg has received research support from CLENE Nanomedicine. The institution of Dr. Greenberg has received research support from Anokion. The institution of Dr. Greenberg has received research support from Regeneron. Dr. Greenberg has received intellectual property interests from a discovery or technology relating to health care. Dr. Greenberg has received publishing royalties from a publication relating to health care.
No disclosure on file
No disclosure on file
Marjan Sepassi (Clene nanomedicine) Dr. SEPASSI has received personal compensation for serving as an employee of Clene Nanomedicine .
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file