Multiple Doses of AT-1501-A201 in Adults With ALS

Inclusion Criteria:

ALS diagnosed as possible, laboratory supported probable, probable, or definite as defined by revised El Escorial criteria
ALS Functional Rating Scale - Revised (ALSFRS-R) Aggregate score of 37 or greater
No more than 24 months from diagnosis

Exclusion Criteria:

Any other central or peripheral nervous system disease that may interfere with the evaluation of ALS or its progression
Presence of a tracheostomy, or use of permanent assistive ventilation (ventilatory support for 23 hours per day or more)
History of malignancy within the previous 5 years, except for localized non-melanoma skin cancers

Abnormal function of the immune system resulting from:

Clinical conditions affecting the immune system (e.g. HIV infection, agammaglobulinemia),
Systemic administration of corticosteroids (PO/IV/IM) at a dose equivalent to 20 mg/day of prednisone for more than 14 consecutive days within 90 days prior to screening,
Administration of anti-neoplastic and/or immunomodulating agents (e.g. Tumor necrosis factor alpha (TNF α) antagonists or anti-B cell antibodies) or radiotherapy within 1 year prior to screening.
Recipient of Stem Cell or Gene Therapy
Positive test for Hepatitis B surface antigen, Hepatitis C antibody, or HIV.
History of deep venous thrombosis or pulmonary embolism
History of active substance abuse within the past 2 years
History of stroke, poorly controlled or significant cardiovascular disease, diabetes