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Marinus Considers Its Options After Mixed Phase III Data

 
• By Joseph Haas

Ganaxolone met one of two endpoints in its Phase III refractory status epilepticus trial, but next steps are uncertain. Analysts say the firm should focus on a more promising trial, but Marinus thinks conditional approval is possible.

Seizures
Marinus is looking to add more seizure indications to ganaxolone's label • Source: Shutterstock

Marinus Pharmaceuticals, Inc. got mixed results on 17 June from a Phase III trial of the intravenous formulation of neuroactive steroid ganaxolone in the rare severe seizure condition refractory status epilepticus (RSE), but it is unclear what its next steps will be. Multiple analysts recommended the company focus primarily on an expected Phase III readout of oral ganaxolone in tuberous sclerosis complex (TSC), which may offer Marinus the best near-term market potential.

Key Takeaways

  • Marinus hits one of two co-primary endpoints with I.V. ganaxolone in refractory status epilepticus, and is pondering another study or seeking conditional approval.

  • After...

Formed in 2003, Marinus has been focused solely on development of ganaxolone, a positive allosteric modulator of GABA alpha, enduring multiple trial failures until the oral formulation obtained US Food...

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