WASHINGTON, Dec 27: A new experimental drug may help restore cardiac function after heart failure, according to the results of its first human trial.
Heart failure, characterised by a loss of cardiac function, is among the leading causes of death worldwide.
A significant portion of heart failure patients, particularly those with severe left ventricular systolic dysfunction, do not sufficiently respond to current medical therapy.
Researchers from Vanderbilt University in the US examined the safety and efficacy of a single infusion of the drug cimaglermin, which acts as a growth factor for the heart, helping the structural, metabolic and contractile elements of the heart to repair itself following injury.
The study enrolled 40 heart failure patients who were taking optimal medical therapy for at least three months prior to the trial.
Compared to patients who received a placebo, those who received a high dose of cimaglermin had a sustained increase in left ventricular ejection fraction, or pumping capacity, through 90 days after dosing, with the maximum increase reached at day 28.
“These findings support continued clinical development of the investigational drug cimaglermin, including further safety evaluations and detailing the potential improvement on clinical heart failure outcome measures,” said Daniel J Lenihan from Vanderbilt University.
“As with all experimental therapeutics, additional studies will be required and subject to regulatory review to determine if the relative risks and benefits of cimaglermin warrant approval,” said Lenihan.
The most common side effects were headache and nausea, which were temporarily associated with exposure to the drug, researchers said.
One patient receiving the highest planned dose of cimaglermin experienced an adverse reaction that met the stopping criteria of US Federal Drug Administration guidance for drug induced liver injury, they said.
The study was published in the journal JACC: Basic to Translational Science. (AGENCIES)
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