TiumBio to Release Interim Results of Hemophilia New Drug Phase 1a Clinical Trial by the End of This Month

Tiium Bio, a specialized company in research and development of treatments for rare and intractable diseases, announced on the 10th that it will present the clinical 1a phase results of TU7710, a new drug under development for hemophilia treatment, for the first time at the International Society on Thrombosis and Haemostasis (ISTH). ISTH is a global academic conference where experts in blood disorders such as hemophilia and thrombosis gather to present the latest clinical research results and share new treatment methods. It will be held from the 22nd to the 26th in Bangkok, Thailand.

TiUM Bio logo [Photo by TiUM Bio]

At ISTH, Tiium Bio will disclose that it confirmed excellent interim clinical results in the clinical 1a phase evaluating the safety, pharmacokinetics, and pharmacodynamics of TU7710, a bypass factor treatment for hemophilia, in healthy adult males.

In the initially released research abstract, the average half-life of the TU7710 100μg/kg dosing group (Cohort 1) was 14.81 hours, and the 200μg/kg dosing group (Cohort 2) showed 12.33 hours, securing data of a half-life 6 to 7 times longer than that of the existing treatment NovoSeven. Additionally, no serious side effects such as thrombosis-related adverse reactions were observed, confirming excellent tolerability and safety.

About 30% of hemophilia patients develop neutralizing antibodies against existing hemophilia treatments. The therapeutic agents developed for these patients are recombinant bio-pharmaceuticals of coagulation factor VII, such as TU7710. The market size for hemophilia treatments for patients with neutralizing antibodies is estimated to be about 2 trillion KRW. Currently, NovoSeven, developed by Novo Nordisk, monopolizes the market. However, its short half-life of approximately 2 hours and high treatment costs are pointed out as limitations.

Kim Hoon-taek, CEO of Tiium Bio, stated, “In the second half of this year, we plan to officially start global clinical trials targeting actual hemophilia patients in Europe to confirm the safety, tolerability, and pharmacokinetic characteristics of TU7710,” adding, “We will actively promote TU7710 in the global market to become a new treatment option for hemophilia.” Meanwhile, Tiium Bio plans to additionally disclose data on the 400μg/kg and 800μg/kg dosing groups (Cohorts 3 and 4) at the conference venue.

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