A heart failure drug that reduces scar tissue

Melbourne-based drug development company Armaron Bio has begun its Phase II clinical trial for NP202, its lead candidate drug for heart failure.

Each year, around 54,000 Australians suffer a heart attack. One of the consequences of heart attack is heart failure, a condition where the heart muscle becomes scarred and too weak to pump blood around the body. Around 50% of heart attack survivors die within five years from heart failure.

NP202 is different from existing heart failure treatments in that it actively reduces the build-up of scar tissue that causes heart failure, prevents cardiac remodelling and improves cardiovascular function. The drug could thus be given to patients immediately following a heart attack, with the Phase II trial aiming to show improvement in heart function of heart attack patients 90 days after being administered with the drug.

The double-blind, placebo-controlled, randomised trial will enrol 120 heart attack patients across 20 sites in Australia, New Zealand and the US. The primary endpoint of the trial is the change from baseline in the heart’s size and function, as assessed by an MRI, between treatment groups. The trial results are expected in the second quarter of 2017.

“This trial is an important step in developing new treatments for this devastating condition, which affects so many heart attack patients,” said Professor Andrew Boyle, the principal investigator at Newcastle’s John Hunter Hospital. “In laboratory studies, NP202 actively treats the cause of heart failure rather than simply managing blood pressure and clearing fluid. We will study whether this benefit will also be seen in our heart attack patients.”

The Phase II trial follows a successful Phase I trial of NP202 in healthy males in both a single ascending dose and multiple ascending dose. In both parts of the trial, the drug was found to be safe and well tolerated.