1. Scrip
  2. >>R&D
  3. >>Clinical Trials

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.

Formed in 2003, Marinus has been focused solely on development of ganaxolone, a positive allosteric modulator of GABA alpha, enduring...

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
Start Free Trial

Already a subscriber?

More from Clinical Trials

Boehringer Ingelheim Expects Two Key Approvals In Second Half Of 2025

 
• By Andrew McConaghie

The privately held German pharma firm is hoping to bring a new generation of pulmonary fibrosis and cancer drugs to market but their commercial success is not yet a certainty.

Memo Therapeutics Plans BK Virus Therapy Phase III Despite Trial Miss

 
• By Manas Mishra

Pointing to data that show a benefit in reducing viral load and the histological signs of the infection, Memo says its drug, potravitug, could become the first therapy to treat BK polyomavirus in kidney transplant recipients.

AZ Poised To Bring Self-Administered C5 Inhibitor To Market

 
• By Jessica Merrill

Gefurulimab will give AstraZeneca a new option to compete against Argenx’s Vyvgart Hytrulo, which is available subcutaneously.

Leo Looks To Grow In US After Hand Eczema Cream Approval

 
• By Kevin Grogan

The Danish medical dermatology specialist doubles boosts its sales force ahead of the launch of Anzupgo.

More from R&D

Leo Looks To Grow In US After Hand Eczema Cream Approval

 
• By Kevin Grogan

The Danish medical dermatology specialist doubles boosts its sales force ahead of the launch of Anzupgo.

Obesity Beyond GLP-1s: Amylins – The Next Frontier

 
• By Aakash Babu

In this series of articles, we look at different mechanisms of actions beyond GLP-1s that could determine the obesity drug landscape in the coming years. First on our list – amylin receptor agonists, which analysts expect to grow into a $50bn market opportunity.

Where Next For Biologics In COPD After Roche’s Astegolimab Phase III Missfire?

 
• By Sushmita Panda

The Phase III failure could dent Roche’s hopes of entering the COPD market with its novel therapy, despite its success in a large Phase IIb trial. It also marks another disappointment for the anti-IL33/ST2 approach.