The US FDA has given Orphan drug status to the PrimeC ALS therapy from Israel’s NeuroSense (see here). Meanwhile, NeuroSense has begun Phase 1 human clinical trials of PrimeC at two US sites and a Phase 2a human trial at Tel Aviv’s Sourasky Medical Center.

https://alsnewstoday.com/2020/02/12/als-combination-therapy-primec-receives-fdas-orphan-drug-designation-enters-clinical-trials/