TiumBio Co., Ltd. has announced the filing of a Clinical Trial Application (CTA) with the Italian Medicines Agency (AIFA) and the Spanish Agency of Medicines and Medical Products (AEMPS) to initiate a Phase 1b study of TU7710, a novel recombinant activated factor VII (rFVIIa) for hemophilia patients with inhibitors. The Phase 1b clinical trial is an open-label, single and multiple-dose escalation study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of TU7710, aiming to determine the recommended Phase 2 dose. The trial will enroll up to 18 hemophilia A or B patients with inhibitors and will be conducted in Italy and Spain.

TU7710 is a long-acting rFVIIa with a half-life 6-7 times longer than NovoSeven, a rFVIIa widely accepted as a standard treatment, which is achieved through TiumBio's transferrin fusion protein technology. Thus, it will substantially reduce both burdens of treatment costs and frequent dosing of NovoSeven for patients. TiumBio is currently conducting a Phase 1a study to evaluate the safety, tolerability, Pharmacokinetics, and pharmacodynamics the TU7710 in healthy adult male volunteers.

Interim results from the study will be present at the ISTH 2024. Hemophilia is a congenital bleeding disorder caused by the absence of deficiency of blood clotting factors. Blood coagulation factor VIII deficiency is classified as hemophilia type A, and blood coagulation factor IX deficiency is classified as hemophili type B. rFVIIa is a bypassing agent therapy for patients with hemophilia A or B who develop neutralizing antibodies, but there are currently only limited treatment options available on the market, including the leading drug NovoSeven, a product by Novo Nordisk.