Capricor Therapeutics’ (NASDAQ:CAPR) Phase I/II HOPE and ALLSTAR trials investigating CAP-1002 for cardiomyopathy secondary to Duchenne muscular dystrophy (DMD) and myocardial regeneration, respectively, are demonstrating strong safety profiles, two trial investigators said.
HOPE (NCT02485938) is demonstrating no concerning toxicities and an unsubstantial drop-out rate, said a first investigator. ALLSTAR (NCT01458405) is demonstrating no toxicities or patient drop-outs to date, the second investigator said. HOPE is a randomised, open-label trial, whilst ALLSTAR is randomised and double-blind.
The investigators declined to discuss the trials further.
On the 7 September and 5 October, Capricor announced HOPE and ALLSTAR respectively had completed enrolment with top-line six-month data being due to report in 1Q17. According to ClinicalTrials.gov, both studies are recruiting and are due to complete in August and September 2017, respectively. The drug’s effects on heart structure and function, scar tissue and heart muscle growth in heart failure development are being assessed as primary and secondary endpoints in its ongoing trials.