MEDIA RELEASE, 2 December 2024, Brisbane AU and Seattle, US:
The US Food & Drug Administration has approved the commencement of a clinical study of Implicit Bioscience’s monoclonal anti-CD14 antibody atibuclimab (IC14) in patients with acute decompensated heart failure (ADHF).
Atibuclimab targets a central regulator of inflammation that has recently been shown in a thirty-year study to be more predictive of adverse cardiac outcomes than cholesterol levels (Ridker, NEJM, 2024).
The first ADHF patient to be treated with IC14 at the University of Virginia hospital in Charlotteville is reported by the clinical study Principal Investigator to have responded very well to a single dose of IC14.
Cardiovascular diseases are the leading cause of death globally with 60% of US adults projected to have cardiovascular disease by 2050, with an associated cost rising to $1.8 trillion (Maddox, 2024).
Heart failure is the greatest unmet medical need in this broad category and patients with end-stage disease known as “acute decompensated heart failure” (ADHF) are very limited in medical treatment choices, with heart transplant as the final option.
Implicit Bioscience CEO and MD, Garry Redlich, commented: “Data from our research collaborations with leading research institutes in the USA and Australia showing the power of modulating the immune system in cardiovascular disease have been reviewed by the FDA and supported their go-ahead to commence treating these very sick patients.
“With more than 1 million hospitalizations for heart failure in the US and Europe each year and an astounding 24% readmission rate within 30 days for patients with ADHF, heart failure represents a massive and growing cost to healthcare systems which we hope to be able to turn around.”
This approval adds to FDA authorizations already held by Implicit Bioscience for the clinical study of IC14 in arrhythmogenic cardiomyopathy, ST-elevation myocardial infarction, acute respiratory distress syndrome and amyotrophic lateral sclerosis.
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