NEW YORK, Feb. 26, 2020 (GLOBE NEWSWIRE) -- Seelos Therapeutics, Inc. (SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced additional interim data from its Phase I pharmacokinetic/pharmacodynamic (PK/PD) studies of Intranasal Racemic Ketamine (SLS-002).
Interim data disclosed here includes all 42 subjects from study SLS-002-101 and 38 out of 62 subjects from study SLS-002-102. Interim data from both studies has demonstrated that doses of 30mg, 60mg, 75mg and 90mg of SLS-002 have been generally safe and well-tolerated.
Some of the key highlights of the interim safety findings from these 80 subjects include:
There have been no discontinuations due to drug related adverse events (AEs).
There have been no serious adverse events (SAEs).
The vast majority of AEs have been mild or moderate, have been transient in nature and have not revealed any new or unique safety signals.
Only 5 out of 80 subjects have experienced severe AEs that were transient in nature, consistent with the known profile of the drug, and all AEs resolved without medical intervention.
“This additional interim data speaks to the safety profile of SLS-002 that we have seen so far. We have dosed over 80 subjects across both studies, including doses up to 90mg, and have not seen any SAEs,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “We look forward to our Type C meeting with FDA in March for input and feedback on our proposed adaptive Phase III trial design for SLS-002 for Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).”
Additional data from the Phase I studies is expected to be released late in the first quarter and early in the second quarter of 2020.
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 interim results of study SLS-002-101 and SLS-002-102, the safety profile of SLS-002, final data and safety findings from study SLS-002-101 and study SLS-002-102, the expected timing for releasing additional data from study SLS-002-101 and study SLS-002-102, expectations regarding the Type C meeting with the Food and Drug Administration and expectations regarding Seelos’ proposed Phase III trial design for 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 with Seelos' business include, but are not limited to, the risk of not successfully executing its clinical studies, including study SLS-002-101 or study SLS-002-102, 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, risks related to Seelos’ 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.
Head of Corporate Communications
Seelos Therapeutics, Inc. (SEEL)
300 Park Ave., 12th Fl
New York, NY 10022