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

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

 
• By Emily Hayes

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

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

Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By Joseph Haas

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.

CRISPR Therapeutics Unveils Promising Early In Vivo Cholesterol-Lowering Results

 
• By Andrew McConaghie

The Phase I results are the best to date among ANGPTL3-targeting candidates in the pipeline, but analysts will wait for further updates before predicting a likely winner.

Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

Marea Eyes Cardioprotective Benefit With ANGPTL4 Inhibition

 
• By Joseph Haas

Phase IIa data for ANGPTL4-targeted antibody shows reduced triglycerides and remnant cholesterol, which Marea asserts indicates potential to protect against cardiovascular outcomes.

More from R&D

First Win For AstraZeneca’s Enhertu In Early-Stage Breast Cancer Treatment

 
• By Andrew McConaghie

Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.

In Brief: Strong OS Results For Immutep’s Eftilagimod/Keytruda Combo In Head And Neck Cancer

 
• By Sushmita Panda

Australian firm's combo of eftilagimod and Keytruda shows 17.6-month median overall survival in first-line HNSCC patients with low PD-L1, raising hopes for potential accelerated approval.

In Brief: Positive New Data For Aptose’s Triplet Therapy In 1L AML

 
• By Sushmita Panda

Aptose’s tuspetinib triplet shows early mutation-agnostic promise in new data from Phase I/II program for frontline acute myeloid leukemia.