Summary:
- Arrhythmogenic cardiomyopathy (ACM) causes sudden cardiac death in young adults and has no current drug treatment.
- Extensive study of Implicit’s antibody show that that it treats ACM and restores normal heart rhythm in animal models.
- The FDA has approved commencement of atibuclimab in ACM and designated it as an Orphan Drug for the disease.
Implicit Bioscience based in Brisbane (Australia) and Seattle (USA) has received approval from the US Food and Drug Administration (FDA) to commence clinical trials of its monoclonal antibody drug candidate, atibuclimab (IC14) in patients with a life-threatening cardiomyopathy.
Arrhythmogenic cardiomyopathy (ACM) is estimated to affect up to 100,000 individuals in the USA and up to 10,000 in Australia. It is frequently undetected until sudden cardiac death occurs in early adulthood during strenuous exercise. ACM accounts for around half of such incidents during football matches. Some examples of sudden cardiac death in sports may be seen in this video from the UW Medicine Center for Sports Cardiology.
ACM mostly results from genetic mutations that are found in other family members related to the patient and who are therefore also at high risk of suffering heart damage and SCD.
There is no drug treatment for ACM and patients receive an implanted defibrillator that detects potentially life-threatening ventricular arrhythmias and repeatedly shocks the heart until normal rhythm returns. This can happen at any time of the day or night and many ACM patients suffer consequential post-traumatic stress disorder. Heart transplant as the only long-term therapeutic intervention currently available.
Implicit Bioscience commissioned two independent studies using its proprietary monoclonal antibody as a treatment in an animal model of ACM at leading university laboratories in the USA. The FDA reviewed these data and Implicit’s proposed clinical protocol and has now issued a Study May Proceed letter permitting the commencement of atibuclimab dosing in ACM patients at the Washington University in St Louis Center for Cardiovascular Research early in 2024.
These and other studies in cardiology show that Implicit’s antibody treatment works by re-wiring the genome of the immune cells that cause heart damage triggered by acute injury such as a heart attack or resulting from chronic injury driven by genetic causes.
Implicit Bioscience CEO, Garry Redlich, commented: “Heart disease is the leading cause of death globally and the recent COVID pandemic has only made things worse. The new science of cardioimmunology now offers us the chance to transform this field by selectively altering the transcription of the genes of immune cells that underlie chronic inflammation and disease in patients.”
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