TiumBio Co., Ltd., a trailblazer in the biopharmaceutical landscape, dedicated to crafting groundbreaking therapies for rare and untreatable diseases, has officially announced its submission of a Clinical Trial Application (CTA) to both the Italian Medicines Agency (AIFA) and the Spanish Agency of Medicines and Medical Products (AEMPS). This pivotal move marks the commencement of a Phase 1b clinical trial for TU7710, an innovative long-acting recombinant activated factor VII (rFVIIa), specifically designed for hemophilia A or B patients harboring inhibitors.

Scheduled to unfold in Italy and Spain, this open-label, single and multiple-dose escalation study will meticulously evaluate TU7710's safety, tolerability, pharmacokinetics, and pharmacodynamics. The ultimate goal is to pinpoint the optimal dose for Phase 2. Up to 18 individuals grappling with hemophilia A or B and inhibitors are set to participate in this trailblazing trial.

TU7710 stands out for its extended half-life, which is 6-7 times longer than that of NovoSeven, the current rFVIIa treatment standard. This leap forward is attributed to TiumBio's sophisticated transferrin fusion protein technology, promising to significantly alleviate the treatment and cost burdens associated with frequent dosing.

Currently, TiumBio is in the midst of a Phase 1a study, assessing TU7710 in healthy adult male volunteers. The interim findings from this study are eagerly awaited at the upcoming International Society on Thrombosis and Haemostasis (ISTH) 2024 Congress.

Dr. Hun-taek Kim, the visionary Founder and CEO of TiumBio, expressed his confidence in TU7710's potential to redefine the management of bleeding episodes and surgical bleeding prevention, thanks to its prolonged half-life compared to NovoSeven. This optimism is bolstered by the team's proven track record with Afstyla, a recombinant Factor VIII discovered by TiumBio's R&D team during their tenure at SK Chemicals and now FDA-approved.

Hemophilia, a genetic disorder characterized by inadequate blood clotting due to the deficiency or absence of clotting factors, manifests as type A or B based on the specific factor deficit (VIII or IX, respectively). With limited therapeutic options available for patients who develop neutralizing antibodies, TU7710 is poised to offer a new horizon in hemophilia care, challenging the status quo established by NovoSeven and other market incumbents.