Policy & Regulation
TiumBio files Clinical Trial Application to start Phase 1b TU7710 study
27 March 2024 -

TiumBio Co. Ltd (Kosdaq: 321550), a South Korea-based clinical-stage biopharmaceutical company, announced on Tuesday that it has filed a Clinical Trial Application (CTA) with the Italian Medicines Agency (AIFA) and the Spanish Agency of Medicines and Medical Products (AEMPS) to commence a Phase 1b study of TU7710, a novel recombinant activated factor VII (rFVIIa) for haemophilia patients with inhibitors.

The Phase 1b clinical trial, an open-label, single and multiple-dose escalation study, is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TU7710, aimed at determining the recommended Phase two dose. The trial is to enrol up to 18 haemophilia A or B patients with inhibitors and will be carried out in Italy and Spain.

The company says that TU7710 is a long-acting rFVIIa with a half-life six to seven times longer than NovoSeven, a rFVIIa widely accepted as a standard treatment, which is achieved through the company's transferrin fusion protein technology. It is intended to substantially reduce both burdens of treatment costs and frequent dosing of NovoSeven for patients.

Presently, the company is conducting a Phase 1a study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of TU7710 in healthy adult male volunteers. Interim results from the study are expected to be revealed at the ISTH 2024.