FDA signs off on late-stage study of Seelos’s ALS candidate

The FDA has OK’d the initiation of Seelos Therapeutics’s (SEEL +5.5%) Phase 2b/3 trial for SLS-005 (trehalose), for the treatment of Amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease).

The trial will enroll 160 patients, with primary endpoint measuring change from baseline on revised ALS functional rating scale score at 24 weeks.

Secondary endpoints will also be measured at 24 weeks, including change from baseline in slow vital capacity, muscle strength, quality of life measurements as well as additional signs of disease progression.

ALS is a rare neurological disease that mainly involve the nerve cells responsible for controlling voluntary muscle movement.

https://seekingalpha.com/news/3603427-fda-signs-off-on-late-stage-study-of-seeloss-als-candidate-slsminus-005