Seelos Therapeutics has announced an amendment of its agreement with Vyera Pharmaceuticals regarding development of SLS-002 intranasal ketamine. According to Seelos, the company will now not be required to conduct a Phase 3 trial and will make cash and stock payments to Vyera instead of a milestone that would be due on initiation of a Phase 3 trial.
Seelos said that it has held a Type C meeting with the FDA and now intends to conduct a Phase 2 proof of concept study of SLS-002 for the the treatment of suicidality in major depressive disorder.
SLS-002 was originally known as TUR-002, and initiation of a Phase 1 trial of the formulation was announced in 2016 by Turing Pharmaceuticals, which changed its name to Vyera after the arrest of its founder, Martin Shkreli. Vyera has apparently changed its name again and is now operating as Phoenixus AG.
Seelos Chairman and CEO Raj Mehra commented, “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. 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.”
Read the Seelos Therapeutics press release.
