The agreement includes the co-exclusive use and supply of Aptar Pharma’s Bidose device to deliver Seelos’ intranasal ketamine product candidate, SLS-002, for treating suicidality, depression and post-traumatic stress disorder (PTSD).
Under the agreement, Seelos garners certain rights to add other undisclosed indications to the partnership for use with Aptar’s Bidose system, according to a news release.
Aptar’s Bidose system has FDA approval and authorization from the European Medicines Agency to deliver intranasal therapeutics like SLS-002, where a precise delivery of active CNS drug formulations is required.
Seelos has completed part one, a 16-patient, open-label cohort, of its proof-of-concept study using the Aptar Bidose system to deliver 90mg of SLS-002 to patients who are imminently suicidal. This precedes part two, which is a registrational, double-blind, placebo-controlled trial.
The company expects to release open-label data in the second quarter of 2021 once data from part one is analyzed, as the final patient in that cohort completed their part of the study on March 30.
“Aptar is a world-class organization and has been an integral partner for our intranasal ketamine program since our inception,” Seelos chairman & CEO Raj Mehra said in the release. “This partnership strengthens the collaboration between Seelos and Aptar and further protects the SLS-002 franchise.”