Celladon: Negative Results For CUPID2 Trial Of MYDICAR In Advanced Heart Failure

(RTTNews) - Celladon Corp (CLDN) on Sunday said its Phase 2b CUPID2 trial of MYDICAR did not meet its primary and secondary endpoints in advanced heart failure.

CUPID2 is a randomized, double-blind, placebo-controlled trial evaluating a single, one-time, intracoronary infusion of the cardiovascular gene therapy agent MYDICAR (AAV1/SERCA2a) versus placebo added to a maximal, optimized heart failure drug and device regimen.

In the study, the primary endpoint comparison of MYDICAR to placebo resulted in a hazard ratio of 0.93 (0.53, 1.65 95%CI) (p=0.81), defined as heart failure-related hospitalizations or ambulatory treatment for worsening heart failure.

The secondary endpoint comparison of MYDICAR to placebo, defined as all-cause death, need for a mechanical circulatory support device, or heart transplant, likewise failed to show a significant treatment effect.

The efficacy endpoint analyses were performed on the (n=243) modified intent to treat population (mITT), which excludes clinical events that occurred in patients who did not receive MYDICAR or placebo, or which occurred prior to dosing.

All other exploratory efficacy endpoints (improvement in New York Heart Association classification, 6 Minute Walk Test, and Quality of Life) were also inconsistent with a treatment effect. No safety issues were noted.