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news.Celladon, a biopharmaceutical company focused on the discovery and development of treatments for cardiovascular diseases, has released six-month data from its Mydicar Phase 2 clinical trial.
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Celladon said that the new data showed improvements in clinical outcomes and disease markers in advanced heart failure patients treated with the genetically targeted enzyme replacement therapy.
Reportedly, the study met its primary safety and efficacy endpoints for high dose Mydicar versus placebo. The primary efficacy endpoint is a composite endpoint that encompasses the simultaneous assessment of patients’ clinical outcomes, exercise tolerance, heart failure symptoms, biomarkers, and cardiac function.
Barry Greenberg, professor of medicine at the University of California, San Diego, has presented the data in advanced heart failure patients as a late-breaking trial presentation at Heart Failure Congress 2010, the annual meeting of the Heart Failure Association of the European Society of Cardiology.
The study results showed that there was a reduction in patients treated with high dose of Mydicar in cardiovascular events as defined by death, the need for left ventricular assist device (LVAD) or cardiac transplant, worsening of heart failure or heart failure related hospitalizations, which translated into a of 50% risk-reduction in favor of high dose Mydicar.
In addition, the mean duration of hospitalisation in the Mydicar high dose group during the six-month period was 0.2 days/patient, a substantially shorter period of time than the 2.1 days/patient of the placebo treated group.
Additionally, the patients treated with high dose Mydicar improved in their heart failure symptoms, their exercise tolerance, serum biomarkers and cardiac function.
Krisztina Zsebo, president and CEO of Celladon, said: “The consistency of these improvements across multiple outcomes measures is very encouraging. The positive results of the study suggest that Mydicar might have a significant impact on the progression of advanced heart failure, either slowing it down or possibly reversing the course of the disease, which is tremendous progress for more than 350,000 advanced heart failure patients in the US that are estimated to fall under the CUPID population.”