A Phase 2a Open-Label, Multi-Center Study to Evaluate the Safety and Tolerability of Multiple Doses of AT-1501 in Adults With ALS

Minimum Age:

18 Years

Maximum Age:

N/A

Can participants use Riluzole?

Yes

Inclusion Criteria:

1. ALS diagnosed as possible, laboratory supported probable, probable, or definite as defined by revised El Escorial criteria

2. ALSFRS-R Aggregate score of 37 or greater

3. No more than 24 months from diagnosis

Exclusion Criteria:

1. Any other central or peripheral nervous system disease that may interfere with the evaluation of ALS or its progression

2. Presence of a tracheostomy, or use of permanent assistive ventilation (ventilatory support for 23 hours per day or more)

3. History of malignancy within the previous 5 years, except for localized non-melanoma skin cancers

4. 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. TNF α antagonists or anti-B cell antibodies) or radiotherapy within 1 year prior to screening.

5. Recipient of Stem Cell or Gene Therapy

6. Positive test for Hepatitis B surface antigen, Hepatitis C antibody, or HIV.

7. History of deep venous thrombosis or pulmonary embolism

8. History of active substance abuse within the past 2 years

9. History of stroke, poorly controlled or significant cardiovascular disease, diabetes