Seelos Therapeutics Announces Dosing of Phase I PK/PD Study of Intranasal Racemic Ketamine (SLS-002)
Preliminary Data Expected in the First Quarter of 2020
NEW YORK, Nov. 27, 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 Pharmacokinetic (PK) and Pharmacodynamic (PD) profile study, SLS-002-102.
SLS-002-102 is a two-part, randomized, double-blind, placebo-controlled, parallel and crossover study of intranasal and intravenous ketamine which plans to enroll 62 healthy volunteers.
48 subjects in Part A (parallel) will be randomized into four arms to receive either 30mg, 75mg, 90mg of SLS-002 or placebo over 13 days.
14 subjects in Part B (crossover) will be randomized into three arms; 60mg of IV ketamine followed by 60mg SLS-002, 60mg SLS-002 followed by 60mg of IV ketamine, or placebo over 25 days.
"This study should help clarify SLS-002's safety and tolerability across multiple intranasal doses, as well help to identify and understand any pharmacokinetic or pharmacodynamic differences compared with IV ketamine. This information will assist us in confirming the dosing strategy for the planned proof of concept study in patients with MDD suffering from ASIB," said Raj Mehra, Ph.D., Chairman and CEO of Seelos Therapeutics.
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 Proof of Concept (PoC) study of Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).
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 expectations regarding the scope of SLS-002-102, the expected timing for receiving preliminary data from SLS-002-102 and expectations regarding the results of SLS-002-102, as well as the company's planned phase II study in patients with MDD suffering from ASIB. 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 clinical studies, including SLS-002-102, 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, risks related to our current stock price, 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.