Clene Sees Path Forward For ALS Candidate Despite Late-Stage Trial Failure

Touts Survival Signal

The US firm’s nanoparticle candidate has disappointed in a late-stage ALS trial but experts say secondary survival data could prove a silver lining given an increasingly flexible US regulatory environment.  

gold nanoparticles
Clene's Drug Is An Oral Suspension Of Gold Nanocrystals • Source: Shutterstock

Clene, Inc.’s CNM-Au8 for amyotrophic lateral sclerosis has missed the mark in a Phase II/III trial but positive data in a secondary survival endpoint could help pave the way to market, given recent approvals in the space.

The investigator-initiated Healey ALS Platform trial randomized 161 patients to 30mg or 60mg CNM-Au8 or placebo with standard of care...

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

Boehringer Ingelheim Expects Two Key Approvals In Second Half Of 2025

 

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 

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.

More from R&D

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.

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.