Seelos Therapeutics Inc. (Nasdaq: SEEL) announced the completion of enrollment of 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.
Trehalose is a naturally occurring disaccharide that is widely distributed throughout the biological world and is found in plants, algae, fungi, yeasts, bacteria, insects, and other invertebrates.
“The full enrollment 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,” said Raj Mehra Ph.D., chairman and CEO of Seelos.
Seelos said that its Phase II/III trial (NCT05136885) enrolled 160 participants with either familial or sporadic ALS for a double-blind placebo-controlled trial. Participants were randomized 3:1 (drug:placebo), with the primary endpoint measuring the change from baseline on the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) score at 24 weeks. Secondary endpoints include change from baseline in slow vital capacity, muscle strength, quality of life measurements as well as additional signs of disease progression.
Seelos’ planned expanded access program (EAP) is fully funded by a grant from the National Institute of Neurological Disorders and Stroke under the ACT for ALS. Under this EAP, Seelos plans to enroll 70 patients in a 24-week, open-label study to evaluate SLS-005 in persons with ALS who do not qualify for other ongoing clinical trials, thus offering these patients an experimental treatment that they may not otherwise have access to.
Seelos is also known for its ketamine studies, and last week the company reported that it had dosed the first patients in an ethnobridging study in healthy adult Japanese and non-Asian subjects to compare the safety and pharmacokinetic profiles of SLS-002 (intranasal racemic ketamine).
Seelos consulted and received endorsement from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and from the U.S. Food and Drug Administration (FDA) to conduct this Phase I ethnobridging study.
“This ethnobridging study is an important first step as we begin evaluating the potential for SLS-002 in patients globally,” Mehra said. “Our market research suggests a high unmet global need for a therapy with both antidepressant and antisuicidal effects.”
Study SLS-002-103 will measure elements such as dosage and administration, sample size, inclusion and exclusion criteria, endpoints, and blood sampling. Seelos expects that data from this study will help inform the inclusion of Japanese subjects in the design of a future global trial in patients with major depressive disorder (MDD) at imminent risk of suicide.
March 7, 2023 at 1:56 am
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March 7, 2023 at 8:17 am
It’s a brutal disease.