Jacksonville, FL and Irvine, CA – Jan. 24, 2019 — Espero BioPharma, Inc., a pharmaceutical company focused on the development of late-stage drugs for unmet needs in thrombosis and cardiac rhythm control, today announced that Lee’s Pharmaceutical Holdings Limited and its subsidiaries (collectively “Lee’s Pharmaceutical”) has completed its Phase I study of tecarfarin in healthy volunteers in Hong Kong. Lee’s Pharmaceutical, the exclusive licensee of tecarfarin in China, was granted approval from the China National Medical Products Administration (‘’CNMPA’’) in 2018 to conduct clinical trials investigating tecarfarin as a potential treatment for patients with mechanical heart valves (“MHV”). Tecarfarin is being studied in China as a possible replacement for warfarin.
Tecarfarin is a novel Vitamin K antagonist (“VKA”) oral anticoagulant (“OAC”) taken once daily like warfarin that is Phase III ready in the United States. Tecarfarin is metabolized via tissue esterases rather than the hepatic cytochrome P-450 pathways, which is thought to improve efficacy and safety profile due to more predictable pharmacokinetics and fewer drug-drug interactions.
The technology transfer of tecarfarin drug substance and finished product to a Lee’s Pharmaceutical manufacturing site in China has been completed and an open-label Phase I, sequential cohort, single-dose escalation study in Hong Kong was done to assess the safety and tolerability, as well as to assess pharmacokinetics and pharmacodynamics, of tecarfarin in healthy Chinese volunteers. Following the read-out of the Phase I data, Lee’s Pharmaceutical will initiate discussions with the CNMPA to finalize plans for the design of the Phase III registration enabling study in MHV patients in China.
“We are excited about these milestones in China because tecarfarin may improve stability in maintaining a therapeutic anti-coagulation level in patients with mechanical and prosthetic heart valves, as well as those with renal dysfunction,” said Quang Pham, Chairman and Chief Executive Officer of Espero BioPharma. “Tecarfarin may provide an alternative to warfarin and non-VKA oral anti-coagulants (NOACs) that are contraindicated for use in MHV patients, such as direct thrombin and Factor Xa inhibitors.”
Tecarfarin is a novel vitamin K antagonist (“VKA”) OAC taken once daily like warfarin that is Phase III ready in the United States. Tecarfarin is a retrometabolically designed drug that is metabolized via non-saturable tissue esterases, rather than the hepatic cytochrome P-450 pathways, which make its elimination more predictable, and not subject to the genetic and drug-interactive variability in metabolism seen with warfarin.
Tecarfarin is designed for use in patients who need anticoagulation to prevent thromboembolism, in patients with atrial fibrillation (irregular heartbeat), or AFib, or venous thromboembolism, and in the management of patients with mechanical heart valves for which NOACs are contraindicated.
It is estimated that over 500,000 Americans have mechanical heart valves and up 6 million people in the United States have AFib.
About Espero BioPharma, Inc.
Espero BioPharma is a pharmaceutical company focused on the development of late-stage drugs for unmet needs in thrombosis and cardiac rhythm control. The Company is developing tecarfarin for use in patients requiring chronic anticoagulation, budiodarone for the treatment of refractory AFib and a third novel candidate to treat arrhythmias. Tecarfarin and budiodarone were designed using a retrometabolic drug design process which enables them to target a different metabolic pathway than the pathway targeted by the most commonly prescribed anticoagulants and drugs for the treatment of refractory AFib, respectively, in order to potentially eliminate specific side effects while maintaining or improving effectiveness.
About Lee’s Pharmaceutical Holdings Limited
Lee’s Pharmaceutical Holdings Limited (Hong Kong Exchange Stock Code: 950) is the anti-thrombotic market leader in China. Its pipeline of anti-thrombotic therapies includes tecarfarin, a Phase II anti-platelet drug (anfibatide), a Phase I oral Factor Xa inhibitor anticoagulant (GCC-4401C), and a synthetic anti-thrombotic agent (fondaparinux). Lee’s Pharmaceutical is fully integrated with solid infrastructures in clinical development, regulatory, manufacturing, sales and marketing and currently markets 17 products in the PRC. Lee’s Pharmaceutical focuses on several different areas such as cardiovascular and infectious diseases, dermatology, oncology, gynecology, ophthalmology and others. It has more than 50 products under different development stages stemming from both internal R&D as well as from the recent acquisition of licensing and distribution rights from various U.S., European and Japanese companies.
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