SLS-005 did not significantly slow amyotrophic lateral sclerosis (ALS) progression compared with a placebo in the HEALEY platform trial, according to top-line data showing that the experimental therapy did not ease functional declines nor extend patient survival. The therapy, developed by Seelos Therapeutics, also failed to slow…

An expanded access program for the experimental treatment SLS-005 has dosed its first participant, according to Seelos Therapeutics, the therapy’s developer. The expanded access program, or EAP, is an open-label study allowing access to SLS-005 for people with amyotrophic lateral sclerosis (ALS) who are…

Seelos Therapeutics has finished enrolling patients in its Phase 2/3 clinical trial of SLS-005 to treat amyotrophic lateral sclerosis (ALS), the company announced. The ongoing trial (NCT05136885) recruited 160 patients with familial and sporadic ALS, and top-line results are expected by the second half of…

Seelos Therapeutics is planning to launch an expanded access program (EAP) that gives people with amyotrophic lateral sclerosis (ALS) who are not eligible for clinical trials the opportunity to access the company’s investigational therapy SLS-005. The program will be conducted in collaboration with the Sean M. Healey &…

The first patient has been dosed in an open-label Phase 2 trial that’s evaluating Seelos Therapeutics’ experimental therapy SLS-005 in people with amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases associated with the accumulation of toxic protein aggregates. Called a basket trial because it tests one therapy in…

Dosing has begun in a Phase 2/3 trial of SLS-005, Seelos Therapeutics’ infusion therapy to slow progression in amyotrophic lateral sclerosis (ALS) that is running as the fifth arm of the multi-regimen HEALEY ALS platform trial. The trial (NCT05136885) plans to…

Seelos Therapeutics’ experimental therapy SLS-005 (trehalose) will serve as the fifth arm of the multi-regimen HEALEY trial for amyotrophic lateral sclerosis (ALS), after being cleared by the U.S. Food and Drug Administration and the Mass General Brigham Institutional Review Board. With this final regulatory authorization, Seelos may still…

Seelos Therapeutics has announced plans to start patient dosing in a pivotal Phase 2b/3 trial testing its experimental therapy SLS-005 (trehalose), designed to prevent protein clumping in cells, in adults with amyotrophic lateral sclerosis (ALS) by the close of September. The study is part of the HEALEY ALS Platform…

The European Medicines Agency (EMA) has granted orphan drug designation to Seelos Therapeutics‘ investigational therapy SLS-005 for the treatment of amyotrophic lateral sclerosis (ALS), the company announced in a press release. Orphan drug status in Europe is given to medicines with the potential to be safe and…

A committee with the European Medicines Agency favors designating Seelos Therapeutics‘ investigational therapy SLS-005 (trehalose) an orphan drug as a potential treatment of amyotrophic lateral sclerosis (ALS), the company announced in a press release. The opinion, issued by the Committee for Orphan Medicinal Products (COMP), will now go to the…