JACKSONVILLE, Fla. and IRVINE, Calif., June 4, 2020 /PRNewswire/ — Espero BioPharma, Inc., a pharmaceutical company focused on the development of therapeutics for unmet needs in thrombosis and cardiac rhythm control, today expanded a collaborative partnering effort for its lead product candidate tecarfarin.
Tecarfarin is a Phase III-ready, vitamin K antagonist, taken once a day as an oral anticoagulant like warfarin, but targets a metabolic pathway that is distinct from the one targeted by the most commonly prescribed anticoagulants. In 2019, the Food & Drug Administration (FDA) granted tecarfarin an Orphan Drug Designation (ODD) for treating patients with End Stage Renal Disease (ESRD) and Atrial Fibrillation (AFib). The FDA grants orphan status to drugs that are intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. The ODD program provides a drug developer with certain benefits and incentives, including a seven-year period of U.S. marketing exclusivity from the date of marketing authorization, waiver of FDA user fees, and tax credits for clinical research.
Blood-thinning drugs may be effective in treating Corona Virus Disease 2019 (COVID-19) patients, leading doctors have found, raising hopes of a major breakthrough in the race to find a treatment for the deadly virus. Systemic anticoagulation may be associated with improved outcomes among patients hospitalized with COVID-19, according to a research letter published on May 6, 2020 in the Journal of the American College of Cardiology.
“The pathogenesis of hypercoagulability in COVID-19 is not completely understood. This current global pandemic and unmet needs in anticoagulation underscores the importance of tecarfarin as a potential new therapy for managing patients,” said Quang Pham, Chairman and Chief Executive of Espero BioPharma. “We are accelerating our partnering efforts for tecarfarin to potentially bring this investigative therapy to patients more quickly.”
Individuals with COVID-19 may have a number of coagulation abnormalities (in the direction of an underlying hypercoagulable state), raising questions about appropriate evaluations and interventions to prevent or treat thrombosis. Interim guidance has been published by the International Society on Thrombosis and Haemostasis (ISTH) , and frequently asked questions are posted on the websites of the American Society of Hematology (ASH) and the American College of Cardiology (ACC).
Tecarfarin is a Phase III-ready, vitamin K antagonist, taken once a day as an oral anticoagulant like warfarin. Tecarfarin was designed using a retrometabolic drug design process and targets a metabolic pathway that is distinct from the one targeted by the most commonly prescribed anticoagulants. This gives tecarfarin a better safety profile and potentially eliminates specific side effect while maintaining or improving efficacy.
About Espero BioPharma, Inc.
Espero is a pharmaceutical company focused on the development of therapeutics for unmet needs in thrombosis and cardiac rhythm control. The Company’s portfolio includes Tecarfarin for use in patients requiring anticoagulation and a novel candidate to treat arrhythmias.