TiumBio Files for Phase 1b Trial of Prolonged-Action rFVIIa TU7710 in Hemophilia Patients

TiumBio, a biopharmaceutical firm specializing in treatments for rare and incurable diseases, has submitted a Clinical Trial Application (CTA) to the Italian Medicines Agency and the Spanish Agency of Medicines and Medical Products. This submission is for a Phase 1b clinical trial of TU7710, a novel recombinant activated factor VII (rFVIIa), intended to treat hemophilia A or B patients with inhibitors. The Phase 1b study is designed to be an open-label, escalating single and multiple-dose assessment of TU7710's safety, tolerability, pharmacokinetics, and pharmacodynamics, with the goal of establishing the dosage for Phase 2. The study is set to include up to 18 participants with hemophilia A or B and will take place in Italy and Spain.

TU7710 is distinguished by its extended half-life, which is 6-7 times longer than that of NovoSeven, a current standard treatment for hemophilia. This extended half-life is achieved through TiumBio's proprietary transferrin fusion protein technology, which is expected to significantly reduce the treatment costs and dosing frequency for patients compared to NovoSeven.

In addition to the Phase 1b trial, TiumBio is also conducting a Phase 1a study with healthy male volunteers to evaluate TU7710's safety and pharmacological properties. Preliminary findings from this trial are scheduled for presentation at the International Society on Thrombosis and Haemostasis (ISTH) 2024 Congress.

Hun-taek Kim, TiumBio's Founder and CEO, expressed confidence in TU7710's potential as a highly effective medication for managing bleeding episodes and preventing surgical bleeding, attributing this to its longer half-life. He also highlighted the company's experience with developing innovative treatments, referencing Afstyla, an FDA-approved recombinant Factor VIII, as an example.

Hemophilia is characterized by a deficiency in blood clotting factors, with type A resulting from a lack of factor VIII and type B from a lack of factor IX. rFVIIa serves as a therapeutic agent for hemophilia patients who have developed neutralizing antibodies, with NovoSeven being a leading example.

TiumBio's pipeline includes three main assets: merigolix (TU2670), TU2218, and TU7710. Merigolix is in global Phase 2 trials for endometriosis and uterine fibroids treatment, while TU2218 is an oral immune-oncology therapy that targets TGF-β and VEGF pathways to enhance cancer treatment responses when combined with immune checkpoint inhibitors. The company is dedicated to developing innovative treatments to alleviate the impact of severe diseases.

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