Seelos starts Phase 2/3 for ALS candidate

 Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced the dosing of the first participants in its registrational Phase II/III trial studying the investigational treatment SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion) for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) on the HEALEY ALS Platform Trial.

"Initiating this trial is a major achievement for Seelos and we are honored to be part of the HEALEY ALS Platform Trial. We look forward to offering this investigational therapy to people suffering with this debilitating disease," said Raj Mehra Ph.D., Chairman and CEO of Seelos.  

"We are thankful to all the patients with ALS who participate in the HEALEY ALS Platform Trial and help develop new treatments in a much faster and more efficient approach.  Partnering with Seelos to determine the efficacy of SLS-005 in this platform trial will give answers sooner because of the sharing of data and infrastructure with other regimens in the platform trial," added Merit Cudkowicz, MD, director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital, Chief of the Department of Neurology, and Principal Investigator of the HEALEY ALS Platform Trial.

Seelos' Phase II/III trial (NCT05136885) plans to enroll 160 participants with either familial or sporadic ALS in a double-blind placebo-controlled trial. Participants will be randomized 3:1 (drug: placebo) and studied with a primary endpoint measuring change from baseline on Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) 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. 

If you are a patient (PALS) or caregiver of someone with ALS (CALS) and would like more information, please visit: https://seelostherapeutics.com/patients-and-caregivers/

https://www.biospace.com/article/releases/seelos-therapeutics-announces-dosing-of-the-first-participants-in-a-registrational-phase-ii-iii-trial-of-sls-005-in-amyotrophic-lateral-sclerosis-on-the-healey-als-platform/