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Confident Catabasis Takes Positives From Failed Duchenne Trial Into Phase III

 
• By Kevin Grogan

The US biotech has presented positive data from a mid-stage trial of edasalonexent that had previously missed its primary endpoint and hopes the goals it has set for Phase III will be enough to satisfy regulators.

Next Level
Catabasis is putting its DMD drug into Phase III trials • Source: Shutterstock

Regulators have been less than impressed with data presented by companies seeking the thumbs-up for their Duchenne muscular dystrophy candidates of late, but Catabasis Pharmaceuticals Inc., which itself suffered a clinical setback earlier this year, believes the clinical package it is putting together for edasalonexent represents a compelling case for approval.

The Cambridge, Mass.-based firm is planning to begin a Phase III trial of edasalonexent, an NF-kB inhibitor, in the first half of 2018 on the back of data from the open-label extension of the Phase II MoveDMD trial to assess its efficacy and safety in boys with DMD, aged four-seven

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