TAHO Pharmaceuticals Starts U.S. Phase III Trial for TAH3311 Antithrombotic Film, First Subjects Dosed

TAIPEI, Nov. 19, 2024 -- TAHO Pharmaceuticals Ltd. has commenced the dosing of participants in the U.S. Phase III clinical trial for its leading 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. This was based on a single pivotal bioequivalence study comparing the plasma concentration of TAH3311 to the approved tablet formulation. This pivotal trial is open-label, randomized, and crossover in design, and will include 60 participants.

TAH3311 represents a novel ODF formulation of apixaban, a well-established first-line treatment and gold standard for stroke prevention and thrombosis management. This innovation addresses significant clinical challenges associated with the traditional tablet form of apixaban.

Dr. Howard Lee, Chairman and CEO of TAHO Pharmaceuticals, explained that the company is committed to creating 505(b)(2) new drug formulations to mitigate the clinical drawbacks of current medications. Apixaban, currently available only in tablet form, can be problematic for elderly patients, children, and stroke survivors who face difficulties swallowing. These patients often need to crush tablets and mix them with water, which is laborious and can lead to inaccurate dosing. TAH3311 resolves these issues with its quick-dissolving oral film, which melts on the tongue, requires no water, reduces the risk of choking, enhances patient adherence, and eases the burden on caregivers.

By tackling the clinical limitations of the tablet form and capitalizing on the substantial market potential of apixaban, TAHO Pharmaceuticals is positioning TAH3311 as a significant advancement in anticoagulant therapy.

Apixaban, co-developed by BMS and Pfizer under the brand name Eliquis®, is a direct factor Xa inhibitor approved for multiple thromboembolic conditions. These include reducing stroke risk in non-valvular atrial fibrillation, thromboprophylaxis after hip or knee replacement surgery, treating deep vein thrombosis or pulmonary embolism, and preventing recurrent deep vein thrombosis and pulmonary embolism. With substantial safety benefits, it is the leading novel oral anticoagulant (NOAC). In 2023, various industry reports ranked apixaban as the second-highest-selling drug globally.

TAHO Pharmaceuticals Ltd., founded in 2010, utilizes its proprietary Transepithelial Delivery System (TDS) to overcome the limitations of current drugs and develop innovative dosage forms for niche markets. The TDS platform integrates advanced transdermal and transmucosal delivery technologies, enabling the creation of unique dosage forms such as transdermal patches, ODFs, and buccal films. TAHO's comprehensive product portfolio includes a range of therapeutic areas, including antithrombotic agents, opioid overdose antidotes, addiction treatments, pediatric ADHD, and chemotherapy-induced antiemetics. Among its significant achievements, TAH4411, an ODF for chemotherapy-induced nausea and vomiting, was the first product of its kind to receive regulatory approval and be commercialized in Japan.