Seelos Therapeutics Announces Initial Dosing of Phase I DDI Study of Intranasal Racemic Ketamine (SLS-002)

NEW YORK, Nov. 20, 2019 (GLOBE NEWSWIRE) -- 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 dosing of the first subjects in a Phase I Drug-Drug Interaction (DDI) study, SLS-002-101.

SLS-002-101 is a single-center, open-label study of SLS-002 dosed in combination with two commonly prescribed antidepressants. This study plans to enroll 48 healthy volunteers, studied over 14 days, randomized into two treatment arms and dosed with a combination of SLS-002 and either, venlafaxine ER or sertraline. The primary objective of this study is to evaluate the pharmacokinetic (PK) profile, DDI, and safety measures of SLS-002.  

“The initial dosing of SLS-002 is a very significant event for Seelos and in the development of intranasal racemic ketamine. We hope to initially demonstrate that SLS-002 can be safely dosed in combination with subjects’ current use of two commonly prescribed antidepressants,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “The initiation of the DDI study will be closely followed by an additional Phase I study measuring PK, pharmacodynamics (PD), and safety of multiple, repeated, single doses of SLS-002 as well as IV ketamine.”  

Preliminary data from this study is expected in the first quarter of 2020.

Upon successful completion of the Phase I studies, Seelos plans to conduct a Phase II Proof of Concept (PoC) study of Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).

Seelos recently announced that the FDA has granted Fast Track designation for SLS-002 for the treatment of ASIB in patients with MDD.

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 the expected enrollment size, duration, primary objectives and results of the phase I study of SLS-002 to evaluate the PK, PD and DDI, expectations regarding the timing for receiving data from the phase I study of SLS-002, the initiation and objectives of an additional phase I study of SLS-002 and IV ketamine to measure PK, PD and the safety of multiple, repeated, single doses of SLS-002 and IV ketamine and the phase II proof of concept study and future clinical development of SLS-002 and the treatment of ASIB in patients with MDD. These statements are based on Seelos’ 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 clinical studies and not gaining marketing approvals for its product candidates, 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, 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