Seelos Plans to Study SLS-002 Initially in Suicidality in Major Depressive Disorder
NEW YORK, Oct. 21, 2019 (GLOBE NEWSWIRE) -- Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company, today announced an amendment of the agreement with Vyera Pharmaceuticals for the development of SLS-002. This amendment now removes the requirement to conduct a Phase III trial and converts the one-time cash payment obligation otherwise owed to Vyera for commencement of the Phase III trial to a series a cash and stock payments over the next 9 months.
Based on feedback from its Type C meeting with FDA, Seelos plans to conduct a Phase II Proof of Concept (PoC) trial in Suicidality in Major Depressive Disorder (MDD).
“Amending this agreement for the development of SLS-002 allows us to proceed with our plans to conduct a Proof of Concept study to evaluate the safety, tolerability, and efficacy of SLS-002, as well as exploring the validation of the Sheehan Suicidality Tracking Scale in this population,” said Raj Mehra, Chairman and CEO of Seelos. “Initiating this study in MDD will allow us to pursue development in targeting a huge unmet clinical need as well as potentially provide for a larger market opportunity than PTSD which we also plan to pursue.”
About Seelos Therapeutics:
Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare disorders. The Company's robust portfolio includes several late-stage clinical assets targeting psychiatric and movement disorders, including orphan diseases. Seelos is based in New York, New York.
For more information, please visit our website: http://seelostherapeutics.com, the content of which is not incorporated herein by reference.
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 our estimates of the impact of the amendment of our agreement with Vyera Pharmaceuticals and our plans to conduct a Phase II Proof of Concept (PoC) trial in Suicidality in Major Depressive Disorder (MDD). These statements are based on the company's current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated to Seelos' business include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies, including for SLS-002, and not gaining marketing approvals for our product candidates, the risks associated with the implementation of a new business strategy, the risks related to raising capital to fund our development plans and ongoing operations, as well as other factors expressed in Seelos' periodic filings with the U.S. Securities and Exchange Commission, including its 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
Head of Corporate Communications
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Ave., 12th Fl
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
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