Seelos Therapeutics Receives an Acknowledgement Letter of a Clinical Trial Notification from the Australian Government Department of Health Therapeutic Goods Administration for a Pilot Study of SLS-005 in Alzheimer's Disease

A Separate Open-Label Basket Study of SLS-005 is Also Planned in Additional Neurological Indications Including Huntington's Disease

News provided by

Seelos Therapeutics, Inc.

Mar 08, 2022, 08:00 ET

NEW YORK, March 8, 2022 /PRNewswire/ -- Seelos Therapeutics, Inc. (Nasdaq: SEEL), 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.

About SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion)

SLS-005 is a low molecular weight disaccharide (0.342 kDa) that crosses the blood brain barrier and is thought to stabilize proteins and activate autophagy through the activation of Transcription Factor EB (TFEB), a key factor in lysosomal and autophagy gene expression. Activation of TFEB is an emerging therapeutic target for a number of diseases with pathologic accumulation of storage material. In animal models of several diseases associated with abnormal cellular protein aggregation or storage of pathologic material, SLS-005 has been shown to reduce aggregation of misfolded proteins and reduce accumulation of pathologic material. SLS-005 is an investigational treatment and is not currently approved by any health authority for medicinal use.

Forward Looking Statements

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding Seelos' pilot study of SLS-005 for the treatment of Alzheimer's disease, statements regarding Seelos' plan to conduct a separate open-label basket study, statements regarding SLS-005's prospects and expected insights, and statements regarding the Company's potential market opportunity. These statements are based on Seelos' current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos' business and plans described herein include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies, and not gaining marketing approvals for its product candidates, the risk that prior clinical results may not be replicated in future studies and trials, the risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval, the risks associated with the implementation of a new business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos' current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos' periodic filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information:
Anthony Marciano
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Ave., 2^nd Fl.
New York, NY 10022
(646) 293-2136
[email protected]
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos