• Mezagitamab-Handled Sufferers Confirmed Fast and Sustained Will increase in Platelet Counts That Persevered 8 Weeks After the Final Dose By way of to Week 161

• Mezagitamab Had a Favorable Security Profile, with No New Security Signals1

• Takeda Plans to Provoke World Section 3 Trial of Mezagitamab in ITP within the Second Half of FY2024

OSAKA, Japan & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Takeda (TSE:4502/NYSE:TAK) right this moment introduced optimistic outcomes from its Section 2b, randomized, double-blind, placebo-controlled research evaluating the protection, tolerability and efficacy of mezagitamab (TAK-079) in sufferers with persistent or power major immune thrombocytopenia (ITP), a uncommon immune-mediated bleeding dysfunction. ITP is characterised by the accelerated destruction of platelets in blood, leading to a decreased platelet depend and a rise of bleeding that may be debilitating. These information (Summary #LB 01.1) have been introduced on the oral Late-Breakthrough Session on the thirty second Congress of the Worldwide Society on Thrombosis and Haemostasis (ISTH) in Bangkok, Thailand. Takeda plans to provoke a worldwide Section 3 trial of mezagitamab in sufferers with ITP within the second half of FY2024.

The TAK-079-1004 trial (NCT04278924) evaluated three completely different doses of subcutaneous mezagitamab (100mg, 300mg and 600mg) versus placebo, given as soon as weekly for eight weeks in sufferers with power or persistent major ITP, adopted by >8 weeks of security follow-up. The first endpoint is the share of sufferers with a minimum of one Grade 3 or larger remedy emergent opposed occasions (TEAEs), severe opposed occasions (SAEs), and opposed occasions (AEs) resulting in mezagitamab discontinuation.2 Secondary endpoints included platelet response, full platelet response, clinically significant platelet response, and hemostatic platelet response.1,2

The Section 2b trial outcomes demonstrated that mezagitamab remedy improved platelet response in comparison with placebo, throughout all three dose ranges of mezagitamab examined. Sufferers handled with mezagitamab confirmed fast and sustained will increase in platelet counts (above the 50,000/μL therapeutic threshold)4, that endured eight weeks after the final dose via to Week 16, illustrating the fast and post-therapy results of mezagitamab on platelet response.1

• All of the completely different measures of platelet response evaluated have been highest amongst sufferers handled with the mezagitamab 600mg dose, particularly 81.8% achieved full platelet response, 90.9% clinically significant platelet response, and 100% hemostatic platelet response.1
• Fewer mezagitamab-treated sufferers in comparison with placebo had ‰¥1 illness activity-related bleeding AE (17.9% vs 46.2%, respectively).1

Regardless of remedy with at the moment accessible therapies, there’s nonetheless a big illness burden and wish for a illness modifying remedy that individuals dwelling with ITP can tolerate, stated David Kuter, M.D., D.Phil., a number one knowledgeable in ITP and research presenter on the ISTH oral Late-Breakthrough Session. These Section 2b trial outcomes are particularly encouraging as a result of they present mezagitamab’s favorable efficacy and security profile “ setting the stage for the technology of further medical proof for this anti-CD38 monoclonal antibody with best-in-class potential for efficacy in ITP.

On this research, mezagitamab had a good security profile in sufferers with ITP, with no new security alerts and in keeping with prior research of mezagitamab.1 The charges of TEAEs resulting in discontinuation, Grade >3 TEAEs, and SAEs, between the mezagitamab dose teams mixed versus placebo have been 14.3% versus 0%, 17.9% versus 23.1%, and 14.3% versus 7.7% respectively.1

It’s a privilege to have these Section 2b mezagitamab outcomes chosen for presentation as a late-breaking summary on the ISTH Congress, stated Obi Umeh, M.D., M.Sc., Vice President, Franchise World Program Chief at Takeda. Based mostly on these outcomes, we plan to provoke a Section 3 research of mezagitamab in ITP within the second half of FY2024, additional underscoring our objective to develop transformative therapies in therapeutic areas with excessive unmet affected person wants.

About Mezagitamab

Mezagitamab is a totally human immunoglobulin IgG1 monoclonal antibody (mAb), with excessive affinity for CD38 expressing cells (together with plasmablasts, plasma cells, pure killer cells), ensuing of their depletion. Remedy with mezagitamab is designed to ship fast and sustained enchancment in platelet response and to revive platelet counts to purposeful ranges.

Mezagitamab beforehand acquired Orphan Drug Designation for the remedy of ITP and Quick Monitor Designation for remedy of power/persistent ITP from the U.S. Meals and Drug Administration. Mezagitamab is an investigational compound that has not been authorized to be used by any regulatory authority.

In regards to the Mezagitamab Section 2b Trial in ITP

The information introduced on the ISTH oral Late-Breakthrough Session are from a pre-specified interim analysis of the Section 2b trial, a randomized, double-blind, placebo-controlled research evaluating the protection, tolerability, and efficacy of mezagitamab in sufferers with persistent or power major ITP. The trial had two components: 25 individuals have been randomized (1:1:1) to mezagitamab 100mg or 300mg, or placebo in Half Some time 16 individuals have been randomized (2:1) to mezagitamab 600mg or placebo in Half B. Contributors acquired as soon as weekly subcutaneous mezagitamab or placebo for 8 doses, adopted by ‰¥8 weeks of security follow-up.1

The first endpoint is the share of sufferers with TEAEs together with Grade 3 or larger occasions, SAEs and AEs resulting in mezagitamab discontinuation. Secondary efficacy endpoints embrace and are outlined as: platelet response (a platelet depend ‰¥50,000/μL and ‰¥20,000/μL above baseline); full platelet response (a platelet depend ‰¥100,000/μL); clinically significant platelet response (a platelet depend ‰¥20,000/μL above baseline); and hemostatic platelet response (individuals with a baseline platelet depend of

About ITP

ITP is a uncommon, IgG mediated autoimmune illness prompted, partially, by the event of autoantibodies to platelets (and/or megakaryocytes), that are blood parts accountable for stopping or stopping bleeding. It’s characterised by the accelerated destruction of platelets (with or with out impaired manufacturing), leading to a decreased platelet depend and an elevated threat of bleeding, which might be debilitating (together with fatigue and impaired high quality of life), and in extreme instances could also be life-threatening.

The precedent for approval of recent medication on this indication requires that platelet counts be maintained at 50,000/uL or extra for a sustained interval. Roughly 20 p.c of sufferers with ITP don’t obtain a platelet depend above 50,000/uL following remedy with accessible first- and second-line therapies creating important affected person burden and unmet want for a illness modifying remedy that can also be tolerable.3,4

About Takeda

Takeda is targeted on creating higher well being for individuals and a brighter future for the world. We purpose to find and ship life-transforming therapies in our core therapeutic and enterprise areas, together with gastrointestinal and irritation, uncommon ailments, plasma-derived therapies, oncology, neuroscience and vaccines. Along with our companions, we purpose to enhance the affected person expertise and advance a brand new frontier of remedy choices via our dynamic and numerous pipeline. As a number one values-based, R&D-driven biopharmaceutical firm headquartered in Japan, we’re guided by our dedication to sufferers, our individuals and the planet. Our workers in roughly 80 nations and areas are pushed by our goal and are grounded within the values which have outlined us for greater than two centuries. For extra data, go to www.takeda.com.

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References:

1. Kuter D, Pulanic D, et al. Security, tolerability, and efficacy of mezagitamab (TAK-079) in power or persistent major immune thrombocytopenia: Interim outcomes from a section 2, randomized, double-blind, placebo-controlled research. In: Worldwide Society on Thrombosis and Haemostasis (ISTH) Congress; June 22-26, 2024; Bangkok, Thailand. Summary LB 01.1.
2. https://clinicaltrials.gov/research/NCT04278924. Accessed June 2024.
3. Provan D, Donald A, et al. Blood Advances. 2019;26;3(22):3780-3817.
4. Rodeghiero F. Worldwide Journal of Hematology. 2023;117:316“33.

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Japanese Media
Yuko Yoneyama
yuko.yoneyama@takeda.com

U.S. and Worldwide Media
Mark Dole
mark.dole@takeda.com

Supply: Takeda Pharmaceutical Firm Restricted