Biopharmaceutical firm Seelos Therapeutics (NASDAQ: SEEL), which develops treatments for central nervous system disorders and rare diseases, has dosed its first patient involved in a federal program for patients with amyotrophic lateral sclerosis (ALS) who can’t participate in existing clinical trials.
The company plans to enroll 70 patients in a 24-week study to evaluate the effectiveness of its investigational treatment, SLS-005 (trehalose injection), aimed at treating ALS, also known as Lou Gehrig’s disease. Trehalose is a naturally occurring sugar found in various organisms.
The treatment is believed to stabilize proteins and activate autophagy — a process that helps clear out damaged cells. This is achieved by activating Transcription Factor EB (TFEB), a key factor in lysosomal and autophagy gene expression.
Seelos said last month that it has completed enrolling 160 participants in separate mid-stage trials, involving participants with either familial or sporadic ALS, that aim to measure the changes in patients’ functional abilities after 24 weeks.
The Expanded Access Program (EAP) is fully funded through a grant from the National Institute of Neurological Disorders and Stroke (NINDS) as part of the Accelerating Access to Critical Therapies for ALS (ACT for ALS) initiative.
“Initiating this EAP is an important event for Seelos and for patients in need of therapy who cannot participate in existing clinical trials,” Seelos chairman and CEO Raj Mehra said in a statement. “We are grateful for the support from the ALS community, the Healey platform team and for the funding from NINDS.”
ALS is a rare neurological disease that involves the degeneration of nerve cells responsible for controlling voluntary muscle movement. The disease progresses over time, and patients eventually lose their ability to initiate and control voluntary movements.
Most people with ALS die from respiratory failure within 3 to 5 years after the onset of symptoms. Currently, there’s no cure or effective treatment to halt or reverse the progression of the disease.
Seelos’ EAP could offer hope to ALS patients who do not qualify for existing clinical trials and provides them with the opportunity to receive an investigational treatment that may help manage their symptoms and potentially slow down the disease’s progression.
The company’s portfolio includes several late-stage clinical assets targeting other indications such as Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD), spinocerebellar ataxia (SCA), Sanfilippo syndrome, Parkinson’s disease, other psychiatric and movement disorders.
In addition, Seelos is known for its ketamine studies and has recently dosed the first patients in a study comparing the safety and pharmacokinetic profiles of SLS-002 (intranasal racemic ketamine) in healthy adult Japanese and non-Asian subjects. The study will help inform the inclusion of Japanese subjects in a future global trial for patients with major depressive disorder (MDD) at imminent risk of suicide.
April 7, 2023 at 2:16 pm
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