Marinus Considers Its Options After Mixed Phase III Data

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Clinical Trials

GSK’s Nucala Set For Dupixent Face-Off After FDA COPD Nod

 
• By 

The UK major's asthma drug gets a key expanded approval.

Merus Bispecific Impresses In Head And Neck Cancer

 

Updated Phase II results from petosemtamab have impressed ahead of ASCO, outshining Keytruda monotherapy and its bispecific rival from Bicara.

Boehringer’s CMO On How AI, Integrated Evidence Generation Underpin Its Ambitious Launch Plans

 

The German company has big plans for the next five years or so. Scrip speaks to its chief medical officer Lykke Hinsch Gylvin about how it is using AI and other innovative approaches to make good on its ambitions.

Sanofi Makes Alzheimer’s Bet With Vigil Buy

 
• By 

The French drugmaker is expanding its neurology activities with the $470m deal.

More from R&D

Sanofi Makes Alzheimer’s Bet With Vigil Buy

 
• By 

The French drugmaker is expanding its neurology activities with the $470m deal.

New Vaccine Framework Avoided Worst-Case Scenario, Analysts Say

 
• By 

The new US FDA vaccine guidelines introduced on 20 May might cause financial woes for Moderna, but overall vaccine makers should not be as impacted as feared.

Merck KGaA Plans Phase III For Enpatoran After Mixed Phase II Lupus Data

 

The Phase II study testing the novel TLR7/8 inhibitor met the primary endpoint in a cohort of patients with cutaneous lupus erythematosus and systemic lupus erythematosus with rash, but did not in patients with SLE.