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New Pilot Study on Alzheimer’s Disease

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Seelos Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced it has received an acknowledgement letter of a Clinical Trial Notification (CTN) from the Australian Government Department of Health Therapeutic Goods Administration (TGA) for a pilot study of SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion) for the treatment of patients with Alzheimer’s disease. 

“Trehalose’s activity in Alzheimer’s disease is unique as it inhibits both the beta-amyloid pathology and tau aggregates in preclinical rodent models. This activity appears to be intraneuronal, occurring within the cell, which differs from the antibody-focused therapies. Both amyloid precursor protein and tau oligomers are cytoplasmic within the cell and can be acted upon by Trehalose by inducing autophagy and proteasomal systems. Autophagy has been implicated in degradation of other misfolded protein aggregates as well,” said Raj Mehra Ph.D., Chairman and CEO of Seelos. “We expect to gain evidence and important insights into the suitability of SLS-005 in the treatment of these neurological conditions, which are so physically, emotionally and financially devastating to patients and their families.”            

In addition, Seelos received authorization to conduct a separate open-label basket study (ACTRN: 12621001755820) in Australia to evaluate the effectiveness of SLS-005 on disease progression and severity, as well as its safety and tolerability, in participants with selected neurodegenerative diseases including Huntington’s disease.

Australia’s regulatory body for clinical trials, the TGA, and the Australian Government’s Research and Development Tax Incentive provide a very attractive opportunity for small US biotech companies to initiate clinical trials in Australia in an effort to expedite the initiation of studies and utilize the country’s strong clinical trial capabilities.

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editor

Editor in chief for eTurboNew is Linda Hohnholz. She is based in the eTN HQ in Honolulu, Hawaii.

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