Intermediate Expanded Access Protocol (EAP) CNMAu8.EAP02

This is an expanded access trial for Amyotrophic Lateral Sclerosis focused on measuring Expanded access, ALS, Amyotrophic Lateral Sclerosis, CNM Au8, Au8 Read More

Inclusion Criteria:

1. Able to understand and give written informed consent.
2. Male or female participants aged 18 years or greater (inclusive) at the time of ALS diagnosis.
3. Participants whose conditions are defined as "definite ALS" or "probable ALS" or "lab supported probable ALS" or "possible ALS" diagnostic criteria by the revised El Escorial Criteria as determined by a neurologist specializing in ALS (e.g., the Principal Investigator or sub-investigator for this study).
4. Participant is able to daily consume up to 240 mL of the investigational drug suspension without substantial dysphagia, OR can intake the investigational product through a gastrostomy tube.
5. Slow vital capacity greater than or equal to twenty-precent predicted (>=20%). For participants with bulbar onset ALS who may have difficulty performing the assessment, or who have a tracheostomy, enrollment may be approved on a case-by-case basis upon discussion with, and written approval from, the Sponsor's Medical Representative.
6. In the judgement of the Investigator, OR as documented by the ENCALS prediction model (http://encalssurvivalmodel.org/, (Westeneng et al. 2018), the participant's expected survival is greater than six-months.
7. Participants who have established care with a neurologist at the specialized ALS center involved in the study and will maintain this clinical care throughout the duration of the EAP.

Exclusion Criteria:

1. Participant is eligible for participation in the HEALEY ALS Platform trial (NCT04297683).
2. Participant has a history of any clinically significant or unstable medical condition based on the Investigator's judgment that may interfere with assessment of the study objectives.
3. Based on the investigator's judgment, participants who may have difficulty complying with the protocol and/or any study procedures.
4. Participant with clinically significant abnormalities in hematology, blood chemistry, or physical examination not resolved by the Baseline visit which according to Investigator can interfere with EAP participation.
5. Participants with clinically significant hepatic or renal dysfunction or clinical laboratory findings that would limit the interpretability of change in liver or kidney function, or those with low platelet counts (< 150 x 109 per liter) or eosinophilia (absolute eosinophil count of ≥ 500 eosinophils per microliter) at Screening.
6. Participant is involved in another clinical trial or expanded access program, OR has participated in any other investigational drug trial (within 4-weeks prior to screening or at least five-half lives of the investigational product).
7. Females who are pregnant or nursing or who plan to get pregnant during the course of this clinical trial or within 6 months of the end of this trial.
8. Females of child-bearing potential, or men, who are unwilling or unable to use accepted methods of birth control.
9. History of gold allergy.