Thinly traded nano cap Capricor Therapeutics (NASDAQ:CAPR) is up 45% premarket on modest volume in response to its announcement of positive six-month data from its Phase 2 clinical trial, HOPE-2, evaluating lead candidate CAP-1002 in steroid-treated boys and young men with advanced stages of Duchenne muscular dystrophy (DMD).
Interim data were generated from 17 subjects (10 placebo/7 treated) at month 3 and 12 subjects (6 placebo/6 treated) at month 6. About 80% of the participants were unable to walk.
Improvements in tip to tip pinch strength and grip strength were noted at month 6 compared to declines in the control group. Upper limb function declined slightly, but the decline was less than control. Upper limb function improved slightly at month 3 but declined to month 6, however.
A measure of diaphragm strength called inspiratory flow reserve improved at month 3 but the results at month 6 are not provided.
Positive trends in cardiac muscle function were also noted.
On the safety front, only one serious adverse event was reported subsequent to the institution of a premedication strategy with intravenous steroids and antihistamines (in late 2018, the company placed a voluntary hold on dosing after two patients experienced severe immune reactions).
Management will host a conference call this morning at 8:00 am ET to discuss the results.
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