This Phase II trial, sponsored by the Biogipuzkoa Health Research Institute, explores a novel combination therapy for ALS, a market with significant unmet needs. The ALS therapeutics market is projected to grow, driven by increasing prevalence and the demand for effective treatments. If successful, this combination therapy could position Biogipuzkoa as a key player in the ALS space, potentially leading to partnerships or acquisition interest from larger biopharmaceutical companies. The trial's design, including a 6-month open-label extension, may enhance patient retention and data robustness, which is favorable for future commercialization efforts.