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

Touts Survival Signal

 
• By Ayisha Sharma

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 for 24 weeks. CNM-Au8 missed the primary endpoint of slope of change in ALS Functional Rating Scale Revised scores adjusted for mortality according to topline data

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