Overview

The primary purpose of this study is to evaluate the safety and tolerability of VRG50635 in participants with ALS.

Eligibility

Inclusion Criteria:

• Have a diagnosis of ALS according to the Gold Coast Diagnostic Criteria.
• Have either sporadic amyotrophic lateral sclerosis (sALS) or familial amyotrophic lateral sclerosis (fALS).
• Treatment Research Initiative to Cure ALS (TRICALS) risk profile > -6 and < -2.
• Have slow vital capacity (SVC) ≥ 75% of the predicted value.
• Have a score of 3 or 4 on Item #3 (Swallowing) of the Harmonized ALS-FRS-R. Participants with a score of 3 can be enrolled with the Sponsor's approval only if they are able to safely swallow capsules.
• Have a body weight ≥ 45 kg and body mass index (BMI) ≥ 18 kg/m^2.

Exclusion Criteria:

• Have active psychiatric disease, substance abuse, neuromuscular weakness other than ALS, or any other medical condition that, in the opinion of the Investigator, might confound the results of the study or interfere with the intake or absorption of the study drug or participation for the full duration of the study.
• Have a history of unstable or severe cardiac, pulmonary, neurological, oncological, hepatic, or renal disease or another medically significant illness other than ALS precluding their safe participation in this study.
• Have a history of substance use disorder or illicit drug use in the last year.
• Have a history of serious infection (e.g., pneumonia, septicemia) ≤ 4 weeks of Screening; infection requiring hospitalization or treatment with intravenous (IV) antibiotics, antivirals, or antifungals within 4 weeks of Screening; or chronic bacterial infection (e.g., tuberculosis) deemed unacceptable as per the Investigator's judgment.

Additional protocol-defined criteria may apply.