Update written by DDC Research Volunteer Omar Sheikh.
Capricor announced topline results from its HOPE-3 trial on Deramiocel for Duchenne patients. After a year of treatment, Deramiocel patients showed a 54% decrease in upper limb weakening and a 91% decrease in cardiac weakening. The therapy also was safe in line with prior trial results.
These results suggest that Deramiocel can help address critical heart weakness in Duchenne. Next, the company will submit a response to the U.S. FDA including this trial data.
Capricor CEO Dr. Linda Marban offers, “HOPE-3 delivered strong and definitive evidence that Deramiocel can meaningfully improve the course of Duchenne muscular dystrophy”.
As a reminder, Deramiocel is made up of rare cardiac cells that help maintain heart and skeletal muscle in Duchenne. These cells release biological signals called exosomes that encourage healing rather than inflammation.
HOPE-3 is a Phase 3 trial looking at Deramiocel. In this trial, non-ambulatory and ambulatory Duchenne patients receive either Deramiocel or placebo for the first 12 months. Heart health is observed using a cardiac MRI assessment at 12 months.
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Please see the press release shared by Capricor Therapeutics for more details.
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