Celladon gene therapy fails in heart failure study
One of the quarter's most eagerly anticipated data events came up short, as Celladon Corp. (NASDAQ:CLDN) plummeted $11.04 (81%) to $2.64 on Monday after its Mydicar gene therapy missed the primary and secondary endpoints vs. placebo in the CUPID2 Phase IIb trial to treat heart failure.
The recombinant adeno-associated viral (AAV) vector containing the gene for ATPase Ca++ transporting cardiac muscle slow twitch 2 ( ATP2A2; SERCA2A) missed the primary endpoint of reducing time to heart failure-related hospitalizations or ambulatory treatment (HR 0.93; 95%CI: 0.53, 1.65, p=0.81). Mydicar also missed the trial's secondary endpoint, time to all-cause death or need for a heart transplant or circulatory support device. Celladon is conducting PCR analysis of patient biopsies to determine whether Mydicar was present in cardiomyocytes, which could signal what role the delivery mechanism may have played in the study results. ...