Seelos Therapeutics announced an amendment of the agreement with Vyera Pharmaceuticals for the development of SLS-002. This amendment now removes the requirement to conduct a Phase III trial and converts the one-time cash payment obligation otherwise owed to Vyera for commencement of the Phase III trial to a series a cash and stock payments over the next 9 months.
Based on feedback from its Type C meeting with FDA, Seelos plans to conduct a Phase II Proof of Concept (PoC) trial in Suicidality in Major Depressive Disorder (MDD).
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“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 Raj Mehra, Chairman and CEO of Seelos. “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 which we also plan to pursue.”