Seelos Therapeutics Inc (NASDAQ:SEEL) announced Monday it plans to study its SLS-002 intranasal ketamine depression drug in patients suffering from suicidality in major depressive disorder (MDD).
In a statement, the New York-based clinical-stage biopharmaceutical company also said it is amending its agreement with Vyera Pharmaceuticals for the development of SLS-002.
Seelos said this amendment now removes the requirement to conduct a Phase III trial and converts the one-time cash payment obligation -- owed to Vyera for the commencement of the Phase III trial -- to a series of cash and stock payments over the next nine months.
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Based on feedback from its Type C meeting with the Food and Drug Administration, Seelos said it plans to conduct a Phase II Proof of Concept trial in MDD.
“Amending this agreement for the development of SLS-002 allows us to proceed with our plans to conduct a Proof of Concept study to evaluate the safety, tolerability, and efficacy of SLS-002, as well as exploring the validation of the Sheehan Suicidality Tracking Scale in this population,” said CEO Raj Mehra.
“Initiating this study in MDD will allow us to pursue development in targeting a huge unmet clinical need as well as potentially provide for a larger market opportunity than PTSD (post-traumatic stress disorder) which we also plan to pursue.”
Seelos' stock recently traded up 3.4% to $0.95 a share in New York.
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