Milpitas, CA, May 26, 2016 – Armetheon, Inc., a specialty pharmaceutical company developing novel small molecule drugs for cardiovascular diseases, today announced that it has completed the acquisition of budiodarone, an anti-arrhythmic agent in Phase 2 development. In a previous Phase 2 study (PASCAL), it was found that budiodarone reduced atrial fibrillation burden in a dose-dependent fashion. The Company seeks to develop the product candidate for the treatment of ventricular tachycardia (VT) in patients with implantable cardioverter defibrillators (ICDs).
“Budiodarone is an important addition to our pipeline, which along with our lead candidate, tecarfarin, enables us to further leverage our substantial expertise in investigating and developing products that may help to address unmet needs in cardiovascular diseases,” stated Sanjay Kakkar, MD, Armetheon’s Chief Executive Officer. “Armetheon seeks to demonstrate through continued investigation that budiodarone has the potential to provide an alternative to currently available pharmacological treatments, none of which are approved in the US or Europe for use in patients with ICDs. Many patients with ICDs are poorly controlled on current therapies or cannot continue treatment due to safety issues. A safer, more effective anti-arrhythmic agent is needed.”
John Camm, MD, Professor of Clinical Cardiology at St. George’s Hospital, University of London stated, “Over 100,000 ICDs are implanted in the US alone each year. 1 While ICDs are generally effective in terminating a potentially life-threatening ventricular arrhythmia, they do not prevent the recurrence of arrhythmias and many patients require concomitant treatment with an anti-arrhythmic agent. Unfortunately, the available anti-arrhythmic agents all have significant limitations, either with regard to efficacy or safety, if not both. Budiodarone may offer an exciting opportunity to prevent ventricular arrhythmias and reduce ICD firing with the potential to offer a number of advantages including rapid onset of action, predictable dose response, lack of tissue accumulation, and improved clearance.”
Budiodarone is being investigated as an anti-arrhythmic agent for the treatment of ventricular tachycardia (VT) in patients with an implantable cardioverter defibrillator (ICD). In preclinical and Phase 2 clinical studies, budiodarone has displayed rapid onset and offset of action, and its elimination is not CYP450-dependent, suggesting a lower potential for drug interactions. Further, Phase 2 clinical studies suggest that budiodarone is well-tolerated. Preclinical studies to date have not shown evidence of tissue accumulation and have demonstrated potent inhibitory effects on VT. In the largest Phase 2 study to date, it was found that budiodarone reduced atrial fibrillation burden in a dose-dependent fashion. Due to the high unmet need for an alternative anti-arrhythmic agent for the treatment of VT in patients with ICDs, Armetheon is pursuing development of budiodarone in this patient population.
Armetheon, Inc., is a privately held, specialty pharmaceutical company developing and commercializing innovative medicines addressing major unmet needs in cardiovascular disease, initially in thrombosis and cardiac arrhythmias. Armetheon focuses on improved therapies with the goal of increased efficacy, safety, and utility, targeting specialty markets with clearly defined regulatory pathways. Armetheon’s lead candidate, tecarfarin, is being investigated for use as a Vitamin K Antagonist and is currently in Phase 3 development for the prevention and management of thrombosis. Armetheon is also developing its anti-arrhythmic drug candidate, budiodarone, for the treatment of ventricular tachycardia (VT) in patients with implantable cardioverter defibrillators (ICDs). For more information: www.armetheon.com.
Heather Lake, Director of Corporate Development
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1 Sapp et al. N Eng J Med 2016