Armaron Bio, a Melbourne-based drug development company focused on heart failure and other diseases, is pleased to announce that it has begun its Phase II clinical trial for NP202: Novel lead candidate drug for heart failure.
Each year, around 54,000 Australians suffer a heart attack, with a heart attack occurring every nine minutes. 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. While the majority of heart attack patients survive the initial trauma, around 50% of survivors die within five years of their heart attack from heart failure. Heart failure is also one of the biggest killers globally, with more than 22 million cases worldwide and 850,000 new cases each year in the US alone.
If successful, following Phase II clinical trial for NP202, Armaron’s new drug could be given to patients following a heart attack, preventing the scarring that causes heart failure. The Phase II trial aims to show improvement in heart function of heart attack patients 90 days after being administered with the drug. Unlike other treatments, NP202 actively reduces the build-up of scar tissue that causes heart failure.
The double blinded, placebo controlled, randomised clinical Phase II 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 at the 90 day point, between treatment groups.
The trial results are expected in the second quarter of 2017.
“We are very pleased to be commencing this Phase II trial for NP202, our novel treatment for heart failure, a condition which kills 50% of patients within five years of diagnosis and results in more than one million hospitalisations in the USA annually,” said Armaron Bio Chief Executive Officer, Grant McLachlan.
Professor Andrew Boyle, the Principal Investigator at Newcastle’s John Hunter Hospital added: “This trial is an important step in developing new treatments for this devastating condition, which affects so many heart attack patients. 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 the single ascending dose part of the trial, five dose levels were administered to cohorts of eight subjects and NP202 was safe and well tolerated from 50mg up to 1,600mg. A cohort of eight subjects were also given two dose levels for 14 days which showed the drug was safe and well tolerated to the highest dose tested of 1,000mg/day.