Dazucorilant in Patients With Amyotrophic Lateral Sclerosis

Inclusion Criteria:

• Male and female patients ≥18 years of age with Sporadic or familial ALS

• If taking riluzole, edaravone, and/or sodium phenylbutyrate and taurursodiol, mustbe on a stable dose prior to Screening.

Exclusion Criteria:

• History of a clinically significant non-ALS neurologic disorder

• Inability to swallow capsules.

• Human immunodeficiency virus (HIV) or current chronic/active infection withhepatitis C virus or hepatitis B virus

• Women who are pregnant, planning to become pregnant, or are breastfeeding.

• Use of non-invasive ventilation (NIV) or mechanical ventilation via tracheostomy, oron any form of oxygen supplementation.

• Current or anticipated need of a diaphragm pacing system (DPS).

• Currently using glucocorticoids or have a history of regular systemic glucocorticoiduse within the last 12 months.

• Previous exposure or treatment with glucocorticoid receptor modulators orantagonists.