Inclusion Criteria:
- All participants must adhere to contraception restrictions - Female patients of non-childbearing potential due to:
1. Menopause: spontaneous amenorrhea for at least 12 months not induced by a medical conditions such as anorexia nervosa and not taking medications that induced the amenorrhea (e.g., oral contraceptives, hormones, gonadotropin releasing hormones, anti-estrogens, selective estrogen receptor modulators, or chemotherapy) 2. Surgical sterilization - Have possible, probable, probable laboratory supported or definite and definite familial laboratory-supported ALS in accordance with the El-Escorial criteria - Have familial or sporadic ALS.
- With onset of ALS symptoms, specifically onset of muscle weakness within past 48 months - Have slow vital capacity (SVC) of (greater than or equal to) ≥60% - If on riluzole, must be on a stable dose - If on edaravone, must have completed 2 cycles and are expected to remain on the same dose throughout the study - Able to provide informed consent. If the patient is not able to provide written consent due to aggravation of disease condition, written informed consent may be provided by a legally authorized representative - Have venous access sufficient to allow for blood sampling - Have clinical laboratory test results within normal reference range for the population or study site, or results with acceptable deviations that are judged to be not clinically significant Exclusion Criteria:
- Are currently enrolled in, or discontinued from, within the last 30 days, a clinical trial involving an investigational drug or device or off-label use of a drug or device, or any other type of medical research judged not to be scientifically or medically compatible with this study - Have previously completed or withdrawn from this study - Have a history or presence of medical illness including, but not limited to, any cognitive, cardiovascular, hepatic, hematological, renal, endocrine, or psychiatric, or any clinically significant laboratory abnormality that indicates a medical problem that would preclude study participation - Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies - Show evidence of hepatitis C and/or positive hepatitis C antibody - Show evidence of hepatitis B and/or positive hepatitis B surface antigen - Are women who are lactating.
- Have undergone a tracheostomy unless it was removed at least 6 months prior - Are on feeding tube, unless the insertion of a feeding tube is considered prophylactic - Are on nasal intermittent positive pressure ventilation (NIPPV) >4 hours per day or at the discretion of the medical monitor - Have undergone stem cell therapy

• AL-S Pharma

NCT03981536 (First Published: 5/30/2019)