• Males and females ≥18 years of age at the time of informed consent.

• Diagnosed within the previous 1 year with laboratory-supported probable, clinically probable or definite ALS according to the World Federation of Neurology Revised El Escorial criteria.

• Must have familial or sporadic ALS.

• First ALS symptoms occurred no more than two (2) years prior to screening visit ALS disease duration from diagnosis no longer than 12 months at the Screening visit.

• If treated with riluzole, edaravone or any other approved ALS medication, treated with a stable dose for at least 4 weeks prior to Day 1.

• If documented, patient with an ALSFRS-R score progression between onset of the disease and Screening of \> 0.3 per month, confirmed with an ALSFRS-R score progression of ≥ 1 point during a 12 week prior to randomisation.

• Has a score of at least 26 overall, including a score of at least 3 on item #3 and at least 2 on each of the 12 ALSFRS-R individual component items at Screening and at least 2 on each of the 12 ALSFRS-R individual component items at randomisation.

• Seated slow vital capacity (SVC) ≥ 50% of predicted value for gender, height, and age at screening.

• Must be willing and able to comply with the requirements of the protocol and must be available to complete the study.

⁃ Must provide written informed consent to participate in the study.