2020-02-26 08:35:16 SEEL Seelos Therapeutics
02/26/20 02/2608:35 02/26/2008:35 | Seelos Therapeutics announces interim data from Phase 1 studies of SLS-002Seelos Therapeutics announced additional interim data from its Phase I pharmacokinetic/pharmacodynamic studies of Intranasal Racemic Ketamine. 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. There have been no serious adverse events. 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. 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. |
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