The data from both studies have demonstrated that doses of 30mg, 60mg, 75mg and 90mg of the drug, SLS-002, have been generally safe and well-tolerated, the company said. Included in the dataset are all 42 subjects from study SLS-002-101 and 38 out of 62 subjects from study SLS-002-102.
The studies were pharmacokinetic and pharmacodynamic, analyzing how a drug moves through the body and the body’s biological response to it.
“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,” CEO Raj Mehra said in a statement. “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).”
Key interim safety findings include:
- No discontinuations due to drug-related adverse events (AEs);
- No serious adverse events (SAEs);
- The vast majority of AEs have been mild or moderate, transient in nature and have not revealed any new or unique safety signals; and
- 5 out of 80 subjects experienced severe AEs that were transient in nature, consistent with the known profile of the drug, and all AEs resolved without medical intervention.
The company expects additional data late in the first quarter and early in the second quarter.
Seelos previously received Fast Track designation from the US Food and Drug Administration for SLS-002 as a treatment for Acute Suicidal Ideation and Behavior in patients with Major Depressive Disorder.
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