– Seelos expects to release top-line data in its registration directed study of SLS-002 (Intranasal Racemic Ketamine) for Acute Suicidal Ideation and Behavior (ASIB) in adults with Major Depressive Disorder (MDD) in the third quarter of 2023.
– Seelos expects to release top-line data from its registrational Phase II/III trial of SLS-005 in amyotrophic lateral sclerosis (ALS) as part of the HEALEY ALS Platform in the fourth quarter of 2023.
– Seelos has been selected to present a poster of an in vivo study in a non-human primate model for the treatment of Alzheimer’s disease at Neuroscience 2023, the Society for Neuroscience’s annual meeting, to be held in November.
NEW YORK, Aug. 14, 2023 /PRNewswire/ — Seelos Therapeutics, Inc. (NASDAQ:SEEL) (“Seelos”), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today provided its clinical update for the second quarter ended June 30, 2023.
On July 24, 2023, the Company received a letter from The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it regained compliance with Nasdaq Listing Rule 5500(a)(2), as required by the Nasdaq Hearings Panel and the Company’s compliance plan previously provided to Nasdaq. The letter further noted that the Nasdaq Hearings Panel determined to continue the listing of the Company’s common stock.
Seelos Clinical Update
SLS-002 (intranasal racemic ketamine)
- Seelos announced the close of enrollment of the registration directed, double-blind, placebo-controlled study for ASIB in adults with MDD on June 22, 2023. Dosing and patient follow up has been completed, with data collection and evaluation ongoing.
- Top-line data from this study is expected to be released in the third quarter of 2023.
SLS-005 (IV trehalose)
- In April 2023, the first patient was dosed in an Expanded Access Program funded by a grant from the National Institute of Neurological Disorders and Stroke (NINDS) under the Accelerating Access to Critical Therapies for ALS (ACT for ALS) for ALS patients who do not qualify for existing clinical trials.
- Top-line data from its registrational Phase II/III trial in ALS as part of the HEALEY ALS Platform Trial led by Harvard Medical School at Massachusetts General Hospital is expected to be released in the fourth quarter of 2023.
SLS-009 (dysproteolyzer)
- Seelos presented a poster on SLS-009 at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting, held on May 16-20, 2023, in Los Angeles, California titled: SLS-009 Clears Only Mutant Huntingtin Aggregates in a Severe Huntington’s Disease Mice Model.
- Seelos is currently evaluating SLS-009, along with SLS-005, in in vivo models of Alzheimer’s disease.
- Seelos has been selected to present a poster at Neuroscience 2023 on November 11-15, 2023 in Washington, D.C. of an in vivo non-human primate study for treatment in Alzheimer’s disease.
If you or a loved one are having thoughts of suicide, please seek immediate medical help, go to your nearest emergency room, call the Suicide and Crisis Lifeline at 988 or 1-800-273-8255 (TALK).