TAHO Pharmaceuticals Initiates U.S. Phase III Clinical Trial of TAH3311 Antithrombotic Oral Dissolving Film, Dosing First Subjects

TAIPEI,Nov. 19,2024 -- TAHO Pharmaceuticals Ltd. announced the dosing of the first subjects in its U.S. Phase III clinical trial for its lead product,TAH3311,an innovative antithrombotic oral dissolving film (ODF). In July 2023,the U.S. Food & Drug Administration (FDA) accepted TAHO's proposal for a 505(b)(2) NDA submission,based on a single pivotal bioequivalence study comparing the plasma concentration of TAH3311 to the approved tablet formulation. This pivotal,open-label,randomized,crossover trial will enroll 60 subjects.

TAH3311 introduces a groundbreaking ODF formulation of apixaban,a widely recognized first-line treatment and gold standard for stroke prevention and thrombosis management.

Dr. Howard Lee,Chairman and CEO of TAHO Pharmaceuticals,stated:

"Our team at TAHO Pharmaceuticals is dedicated to developing 505(b)(2) new drug formulations to address the clinical disadvantages of existing medications. Apixaban,available exclusively in tablet form,often presents challenges for elderly patients,children,and stroke survivors who have difficulty swallowing. These patients frequently need to crush tablets,mix them with water,and administer them twice daily—a time-consuming and imprecise process that risks dosage loss. TAH3311 overcomes these barriers with a quick-dissolving oral film that melts on the tongue,requires no water,reduces the risk of choking,enhances patient adherence,and alleviates caregiver burden."

By addressing the clinical limitations of the tablet form and leveraging the significant market potential of apixaban,TAHO Pharmaceuticals is advancing TAH3311 as a meaningful innovation in anticoagulant therapy.

About Apixaban

Apixaban (co-developed byBMS and Pfizer under the brand name Eliquis®) is a direct factor Xa inhibitor and has been approved for clinical use in several thromboembolic disorders,including reduction of stroke risk in non-valvular atrial fibrillation,thromboprophylaxis following hip or knee replacement surgery,the treatment of deep vein thrombosis or pulmonary embolism,and prevention of recurrent deep vein thrombosis and pulmonary embolism. With notable safety advantages,it is the leading novel oral anticoagulant (NOAC). According to various industry reports,apixaban was the second-highest-selling drug globally in 2023.

About TAHO Pharmaceuticals Ltd.

Founded in 2010,TAHO Pharmaceuticals Ltd. leverages its proprietary Transepithelial Delivery System (TDS) to overcome the limitations of existing drugs and develop innovative dosage forms for niche markets. The TDS platform combines advanced transdermal and transmucosal delivery technologies,enabling the development of unique dosage forms such as transdermal patches,ODF,and buccal films. TAHO's diverse product portfolio spans a variety of therapeutic areas,including antithrombotic agents,opioid overdose antidotes,addiction treatments,pediatric ADHD,and chemotherapy-induced antiemetics. Among its notable achievements,TAH4411,an ODF for chemotherapy-induced nausea and vomiting,became the first product of its kind to receive regulatory approval and be commercialized in Japan.

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