Stellar Zogenix Phase III Epilepsy Data Lift ZX008's Competitive Position

Company is planning to file in the second half with two pivotal studies, but says it is "worth exploring" with the US FDA whether data from the first study could support an application.

tests

Impressive results from Zogenix Inc.'s first Phase III study of ZX008 (low-dose fenfluramine) in the life-threatening epilepsy condition Dravet syndrome are holding up well so far in comparison to the leading drug in the development space – GW Pharmaceuticals PLC 's Epidolex (cannabidiol, or CBD) – and may support an earlier filing than expected.

In a top-line release on Sept. 29 from Study 1, the first of two pivotal trials to report, Zogenix reported...

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

Memo Therapeutics Plans BK Virus Therapy Phase III Despite Trial Miss

 
• By 

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

 

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 

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

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

 

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.

More from R&D

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

 
• By 

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?

 

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.

Abivax Over The Moon As Obefazimod Storms Phase III

 
• By 

Stock shoots up over 460% on positive results in two ulcerative colitis trials of the oral first-in-class candidate.