Company poised to enter final pivotal trial for novel oral anti-coagulant
Menlo Park, CA, August 28, 2014 – Armetheon, Inc. (www.armetheon.com), a biopharmaceutical company focused on developing novel mid- to late-stage cardiovascular drug candidates, today announced that it has raised $7.0 million in its first round of financing. The Series A round was co-led by AshHill Biomedical Investments and Hercules Bioventures with participation from investors that included Atheneos Capital and eminent biotech entrepreneur and pharmaceutical executive, Dr. Larry Hsu, the founder of Impax Laboratories (NASDAQ: IPXL).
Earlier this year the company reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the final pivotal trial, TACT (Tecarfarin for AntiCoagulation Trial), for Tecarfarin, which is being investigated for all patients who require an oral anticoagulant (OAC), including patients with mechanical heart valves (MHV). Recent clinical guidelines from AHA/ACC recommend the use of a vitamin-K antagonist (VKA) for anticoagulation in patients with a MHV. The guidelines also recommend MHV over bioprosthetic heart valves for patients who are less than 60 years of age. The results from already completed clinical trials and TACT will form the basis of regulatory submission for Tecarfarin.
“The quality of our science and the team is reflected by the stellar syndicate of both institutional and angel investors in this over-subscribed Series A round,” said M. (Ken) Kengatharan, PhD, Co-Founder, President & COO.
“The funds will be used to keep to our NDA filing timeline in 2017 for Tecarfarin,” said Peter Milner MD, FACC Co-Founder and Chairman of Armetheon. “Tecarfarin, if approved, could become an important alternative VKA that is not metabolized via CYP enzymes or handled by P-glycoprotein (P-gp). Studies have shown that existing OACs, including warfarin, interact with CYP-metabolizing enzymes or P-gp.” Milner previously co-founded both CV Therapeutics (NASDAQ: CVTX) and ARYx Therapeutics (NASDAQ: ARYX), and currently serves as CEO of Heart Metabolics Ltd (Ireland).
In addition to Drs. Kengatharan and Milner, Armetheon’s board includes Pascal Druzgala, PhD, Co-Founder, and industry veterans, Jon Saxe and Steven P. James, formerly CEO of Labrys Biologics, Inc. (recently acquired by Teva) and KAI Pharmaceuticals, Inc. (acquired by Amgen).
Tecarfarin is being investigated for use as an oral, once-daily anticoagulant inhibitor of Vitamin K epoxide reductase (VKOR, an important enzyme in the coagulation system) which avoids CYP450-dependent metabolism and renal elimination. In a phase 2 and a phase 2/3 (EMBRACE-AC) clinical studies,this drug candidate improved time in therapeutic range (TTR) in chronically anticoagulated patients. The effect of Tecarfarin on TTR will be further investigated in the TACT clinical trial. TTR was chosen as the endpoint for these trials on the basis of evidence suggesting that better anticoagulation control (as measured by higher TTR) can protect patients from severe or even fatal adverse events. Tecarfarin is monitored using INR, and is being investigated for use without the need for CYP2C9 genotyping since Tecarfarin is not metabolized via the CYP-450 system. In pre-clinical and early clinical studies, the anticoagulant effect of Tecarfarin was reversed by existing and readily available antidotes for VKAs.
Armetheon, Inc. is a privately held San Francisco Bay area based biopharmaceutical company with late-stage clinical drug candidates in development for cardiovascular diseases. The company was founded in 2011 by experienced, successful biotech entrepreneurs and drug developers with funding from AshHill Biomedical investments (http://www.ashhill.net) and Atheneos Capital (http://www.atheneoscapital.com/). Armetheon’s two late-stage small molecule drug candidates are for use in the areas of oral anticoagulation and atrial fibrillation. Locust Walk Partners serves as the key strategic advisors to the company. For more information: www.armetheon.com.
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