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IR News
TiumBio Submits CTA for Phase 1b Clinical Trial of TU7710, a Long-acting Recombinant Activated Factor VII, in Hemophilia A or B Patients
TU7710 has the potential to be a highly effective and long-acting treatment for bleeding episodes as well as for preventing bleeding during surgery or invasive procedures in hemophilia patients with inhibitors
Interim
results from an ongoing Phase 1a study in healthy male volunteers will be presented
at International Society on Thrombosis and Haemostasis (ISTH) 2024 Congress
TiumBio Co., Ltd. (Kosdaq:
321550), a clinical-stage biopharmaceutical company focused on discovering and
developing innovative therapeutics for patients with rare and incurable
diseases, 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 of TU7710 in healthy adult male volunteers. Interim
results from the study will be present at the ISTH 2024.
“We believe that
TU7710 will become a highly effective medication that can
manage bleeding episodes and prevent bleeding during surgical operations with
its longer half-life compared to NovoSeven,” said
Hun-taek Kim, Ph.D., MBA, Founder and CEO of TiumBio. “Our
team has been developing TU7710 as an innovative hemophilia
treatment option, which is strengthened by
our experience with Afstyla, an FDA-approved recombinant
Factor VIII originally discovered by our R&D team members at SK
Chemicals,” he added.
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 hemophilia 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.
About TiumBio Co., Ltd.
TiumBio
(Kosdaq: 321550) is a clinical-stage biopharmaceutical company focused on the
discovery and development of innovative therapeutics for patients with rare and
incurable diseases. Its mission is to expand the hope and happiness of mankind
through our science. TiumBio boasts three leading pipeline assets: merigolix
(code name: TU2670), TU2218, and TU7710, all in various stages of clinical
development.
Merigolix
is a once-daily, oral GnRH receptor antagonist being developed for the treatment
of endometriosis and uterine fibroids and is undergoing in
global Phase 2 clinical trials. TU2218 is a first-in-class oral
immune-oncology therapy targeting TGF-β and
VEGF pathways to promote response rates in cancer patients when
used in combination with immune checkpoint inhibitors. TU7710 is a novel
rFVIIa designed to extend its half-life in order to provide
more clinical benefits to hemophilia patients with inhibitors.
With
its expertise in drug development, TiumBio is committed to the discovery and
development of innovative treatments to ease the burden of debilitating
diseases. For further information, visit our website at www.tiumbio.com/en and connect with us on LinkedIn.
Contacts:
Junseok
Jang, Head of Corporate Communications & Investor Relations
junseokjang@tiumbio.com
Suna
Cho, Manager, Corporate Communications & Investor Relations
sunacho@tiumbio.com
Da-ye
Song, Manager, Corporate Communications & Investor Relations
dayesong@tiumbio.com