Celladon reports failure of Mydicar gene therapy during trial

Celladon reports failure of Mydicar gene therapy during trial

Celladon Corporation’s heart failure gene therapy Mydicar has failed during the phase 2b CUPID2 trial. The experimental treatment could not meet the primary and secondary endpoints in the cases of advanced heart failure.

Last year, FDA had awarded ‘breakthrough’ and ‘fast-track’ status to Celladon’s Mydicar. The gene therapy involved injecting a functioning copy of SERCA2a gene into heart cells to improve heart health and to improve pumping power of heart. Mydicar is a virus designed to deliver a gene that reconstitutes an enzyme that is responsible for contraction of heart muscles.

San Diego-based Celladon received support from Pfizer, Novartis and J&J in a $53 million funding round for phase IIb trials of Mydicar. CUPID2 involved randomized, double-blind, placebo-controlled trial and the gene therapy failed to provide any significant improvement compared to placebo.

Announcing the outcomes of the phase 2b CUPID2 trial, Celladon chief executive Krisztina Zsebo said, "We are surprised and very disappointed that Mydicar failed to meet the endpoints in the CUPID2 trial, and we are rigorously analyzing the data in an attempt to better understand the observed outcome. At the same time we are evaluating our other programs in order to determine the best path forward to maximize shareholder value."

Celladon will hold an investor conference on Monday to share the results of the study. The stock has touched 52-week high of $28.25 in March this year. However, in April, the stock declined and closed at $13.68 on Friday.

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