Armetheon, Inc., is a privately held San Francisco Bay area based clinical stage biopharmaceutical company focused on the development of novel drugs for highly
unmet need in cardiovascular diseases. The company was founded by three successful biotech entrepreneurs and pharmaceutical executives with several years of drug R&D and
company building experience.

Armetheon’s late-clinical stage oral anticoagulant addresses a major unmet need:

  • Oral anticoagulants (or blood thinners) are one of the most commonly prescribed class of drugs and tecarfarin, if approved, could be the first oral anticoagulant in modern medical history that could be labeled for all indications for anticoagulation.
  • Despite introduction several years ago, the newly approved oral anticoagulants that target thrombin or Factor Xa have not displaced warfarin as the no. 1 prescribed oral anticoagulant.  Unlike tecarfarin, lack of an antidote and inability to monitor are major disadvantages of these newer agents which work thru different mechanism of action.
  • In addition, these newly approved agents can’t be used in patients with prosthetic heart valves (especially mechanical heart valves) as per March 2014 American College of Cardiology/American Heart Association guidelines as well as having contraindication or not-recommended warnings on the labels granted by FDA and the European Medicines Agency.
  • There is high interest from both regulatory authorities and the medical community for a safer and better drug to replace warfarin, because it is the no. 1 reason for hospitalization due to adverse and fatal drug reactions.
  • Vitamin K antagonist (VKA) class of oral anticoagulants where warfarin is the dominant drug will remain an important class of drugs for chronic oral anticoagulation.
  • The new VKA tecarfarin solves majority of the problems associated with warfarin and so, upon approval, it is anticipated to become the best-in-class for all patients requiring chronic oral anticoagulation in particular for those patients with prosthetic heart valves where there is no alternative but warfarin. Previous clinical and non-clinical studies suggest a superior profile of tecarfarin compared to warfarin.
  • Tecarfarin is a potential blockbuster drug candidate in the major therapeutic areas of cardiovascular disease and thrombosis at a time when there is a shortage of late stage products in the pipelines of major pharmaceutical companies.

  

Core development program:

 Tecarfarin
(ATI-5923)

Phase III

Potentially best-in-class, late clinical trial stage orally active anticoagulant. It is a potent inhibitor of VKOR that is not metabolized by CYP2C9 enzyme. Unlike, non-monitored oral anticoagulant drugs that are direct inhibitors of thrombin or Factor Xa, tecarfarin, is being developed for use in patients with (i) prosthetic heart valves, and/or (ii) who have renal dysfunction.

   

Non-Core development programs:

Budiodarone*
(ATI-2042)

Phase II (oral)/
Late-preclinical (i.v)

Potentially best-in-class, mid-clinical trial stage anti-arrhythmic agent (both oral and intravenous) being developed for the treatment of patients with atrial fibrillation particularly those who are eligible for ablation or re-ablation particularly in a highly responsive unmet need sub-population.

*Partial ownership