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Seelos' IV-administered sugar therapy fails to improve ALS severity in midstage trial
2024-03-19
临床3期临床结果上市批准临床2期
Seelos plans to meet with the FDA to chart the next steps for its amyotrophic lateral sclerosis treatment.
Seelos had hoped to report a sweet victory for its amyotrophic latamyotrophic lateral sclerosis the IV-delivered sugar failed to distinguish itself in a phase 2/3 trial.
The New York biotech said Tuesday that SLS-005 didnamyotrophic lateral sclerosisimprovement in slowing disease severity compared to placebo, flunking the study’s primary endpoint. The treatment was also unable to spur a statistically significant improvement in patients’ physical function or mortality rates.
Searching for a silver lining, the biotSLS-005nted to a pre-specified subgroup of patients who hadn't also received Amylyx’s now-in-flux treatment Relyvrio. In those 130 patients, SLS-005 demonstrated a 22% improvement in slowing the pace of disease progression and 25% slowing in the pace of respiratory decline. It’s enough of a signal that the company is planning to meet with the FDA to discuss next steps.
All told, Seelos said 31 patients took Relyvrio during the trial, “thus confounding results from this population,” according to a release. Amylyx’s drug was approved in September 2022 based on phase 2 data but its fate is in qneurodegenerationling a subsequent phase 3 study. Company executives are mulling whether to pull the drug off the market.
In the last year, Seelos prioritized ALRelyvrio primary use of SLS-005, pausing enrollment in a mid-stage trial for patients with spinocereAmylyx ataxia type 3 due to financial reasons. SLS-005 is an IV-administered form of trehalose, a nonreducing sugar commonly found in bacteria, fungi, yeast, insects, and plants. Seelos said that the low molecular weight disaccharide can stabilize misfolded proteins and activate autophagy in cells.
The biotech’s lead asset, SLS-002, isALS intranasal form of ketSLS-005n development to treat both PTSD and suicidal ideation in paspinocerebellar ataxia type 3SLS-005
But the biotech will likelSLS-002to raise more money to contketamineelopment, having reported lessPTSDn $3 suicidal ideationo hand as of the emajor depressionanuary, Seelos raised a $4 million direct offering and concurrent private placement but that money is set to be aimed in part at paying off interest payments on an outstanding convertible promissory note.
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