The trial will evaluate SLS-005’s safety and efficacy in 160 patients with either familial or sporadic amyotrophic lateral sclerosis. Credit: mwoot from Pixabay.

Seelos Therapeutics has completed participants enrolment in the Phase II/III trial of SLS-005 (trehalose injection) to treat amyotrophic lateral sclerosis (ALS) in the HEALEY ALS Platform Trial.

The placebo-controlled, randomised, double-blind trial has been designed for assessing the safety and efficacy of a single study drug, SLS-005 (trehalose injection, 90.5mg/mL for intravenous infusion), in ALS patients.

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A total of 160 patients with either familial or sporadic ALS are enrolled in the trial.

In the trial, all participants are randomised into a 3:1 ratio to receive SLS-005 or a placebo.

The change from baseline in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) score measured at 24 weeks is the trial’s primary endpoint.

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Change from baseline in slow vital capacity, quality of life measurements, muscle strength, and additional disease progression signs will be some of the secondary endpoints of the trial.

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The company expects to receive topline data from the trial in the second half of this year.

Seelos chairman and CEO Raj Mehra said: “The full enrolment of this study is a significant milestone for Seelos.

“We look forward to releasing the topline data later this year and initiating the Expanded Access Program later this quarter.”

The company intends to commence an Expanded Access Program (EAP), which is completely backed by a grant from the National Institute of Neurological Disorders and Stroke (NINDS) under the ACT for ALS, late in the first quarter of this year.

It plans to enrol 70 participants in an open-label, 24-week study under the EAP.

The trial will assess SLS-005 in ALS patients who do not qualify for other clinical trials underway.