Celladon Corp (NASDAQ:CLDN) Tanks 80% as Heart Treatment Fails In Trial Print E-mail
By Mary Davila   
Monday, 27 April 2015 18:41

Celladon Corp (NASDAQ:CLDN)’s shares plunged over 80% after the company said that the Phase 2b CUPID2 trial doesn’t meet primary as well as secondary endpoints.

 

CUPID2 is a double-blind and placebo controlled as well as multinational trial assessing a one-time and intracoronary infusion of cardiovascular gene therapy agent MYDICAR as compared to placebo addition to an optimized heart failure device and drug regimen. 

The study demonstrated that first endpoint comparison of MYDICAR for placebo led to hazard ratio of 0.93 that is defined as heart failure-related hospitalizations or for worsening heart failure.

The second endpoint of the agent to placebo as well as need for mechanical circulatory support device was not successful in showing significant treatment effect.

The effective endpoint analyses were done on modified intent for treating population excluding clinical events which happened in patients not receiving MYDICAR or placebo.

Rest of the endpoints were even inconsistent with the treatment effect. However, no safety issues were given.

Krisztina Zsebo, Ph.D., CEO of Celladon, opined that he was surprised as well as disappointed that MYDICAR did not succeed in meeting endpoints in CUPID2 trial and the firm is rigorously analyzing data for trying to improve the observed outcome.

The CEO added that he wanted to express gratitude to investigators as well as patients participating in the study. He also stated that it is evaluating other programs for determining best path forward for maximizing shareholder value.

Barry Greenberg, M.D., FACC, Director, Advanced Heart Failure Treatment Program; Distinguished Professor of Medicine, University of California, San Diego, and the Chairman of the Executive Clinical Steering Committee of the CUPID2 trial, stated that the trial was very good and perfectly well executed and tested the hypothesis. He added that the therapy did not do primary and secondary endpoints but there were no safety issues.




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