Seelos Therapeutics has secured near-global rights to a sublingual ketamine wafer, agreeing to pay iX Biopharma $9 million upfront to take control of a candidate it envisages unlocking chronic use of the drug.
New York-based Seelos already owns an intranasal formulation of ketamine, SLS-002, that recently entered the second part of a registrational clinical trial in patients with major depression at imminent risk of suicide. The sublingual formulation, now named SLS-003, potentially opens up applications for the chronic dosing of ketamine to treat complex regional pain syndrome (CRPS) and post-traumatic stress disorder (PTSD).
In a statement, Seelos CEO Raj Mehra said the formulation may be more suitable for chronic dosing, adding that the current pharmacokinetic, pharmacodynamic and safety profiles of SLS-003 “suggest a formulation with the potential of being prescribed with less restrictions than current formulations.”
Seelos is paying iX $3.5 million in cash and $5.5 million in restricted shares, as well as committing up to $239 million in development and sales milestone payments, for the chance to put that idea to the test. In return, Seelos will secure the rights to SLS-003 outside of greater China, enough product for the treatment of 400 patients and global rights to other sublingual ketamine wafers.
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Having struck the deal, Seelos is now planning to study SLS-003 in the clinic. Seelos is yet to name a lead indication, with CRPS and PTSD sitting alongside chronic neuropathic pain and other psychiatric disorders on the list of conditions that may be amenable to treatment with SLS-003. IX has already run a phase 2 trial in moderate to severe acute pain and received orphan drug designation in CRPS.
The dosage form is designed to disintegrate rapidly when placed under the tongue, resulting in a fast onset of action as the drug molecule is released from the amorphous non-ionic wafer. Through that release mechanism, Seelos aims to expand beyond acute indications, where it is seeking to challenge Johnson & Johnson’s Spravato, and into chronic conditions.