Intermediate Expanded Access Protocol With CNM-Au8 for Multiple Sclerosis

This is an intermediate expanded access program to provide access to the investigational product, CNM-Au8, for up to 25 participants. All participants will receive open label treatment with CNM-Au8 30 mg orally.

The safety and efficacy of CNM-Au8 treatment in MS participants will be evaluated. Scheduled visits will occur at the baseline visit, week 6 visit, week 12, and then every 12-weeks thereafter at the participating clinic(s). Optional remote data collection via telemedicine and/or home healthcare visits are permitted commencing with the week 12 visit. Clinical safety laboratory monitoring including urinalysis, a chemistry panel (e.g., CMP) and a hematology panel (e.g., CBC) will be conducted at the screening/baseline visit and at each scheduled visit incorporating safety laboratory assessments.

Participants who meet the inclusion criteria and none of the exclusionary criteria may be enrolled into the EAP.

The program and participant visits will continue for a total of 96-weeks of treatment. Four weeks following treatment discontinuation, a safety follow-up visit will be conducted.

Investigational product may be shipped by the site to participants who do not attend an in-clinic visit.