Takeda: Mezagitamab Phase 2 Trial Shows Positive Results In Primary Immune Thrombocytopenia

(RTTNews) - Takeda Pharmaceutical Co. Ltd. (TAK, TKPHF.PK) announced Wednesday positive topline results from a Phase 2 trial of mezagitamab (TAK-079) in patients with persistent or chronic primary immune thrombocytopenia or ITP.

Based on these positive results, and following consultation with global health authorities, Takeda plans to initiate a global Phase 3 trial of mezagitamab in ITP in fiscal year 2024.

The TAK-079-1004 trial (NCT04278924), a randomized, double-blind, placebo-controlled study, evaluated the safety, tolerability and efficacy of mezagitamab.

ITP is a rare, IgG mediated autoimmune disease caused, partly, by the development of autoantibodies to platelets, which are blood cells responsible for preventing or stopping bleeding.

Takeda noted that Mezagitamab is a fully human immunoglobulin IgG1 monoclonal antibody (mAb) with high affinity for CD38 expressing cells, including plasmablasts, plasma cells, natural killer cells, resulting in their depletion.

The trial evaluated three different doses of subcutaneous mezagitamab vs placebo, given once weekly for eight weeks in patients with chronic or persistent primary ITP.

Takeda said an interim analysis of the ongoing Phase 2 study demonstrated positive safety and efficacy results. Mezagitamab has been generally safe and well tolerated across all three cohorts. All mezagitamab doses tested demonstrated a higher platelet response rate than placebo.

When mezagitamab advances to Phase 3 in ITP, Takeda will have five new molecular entities in Phase 3 development in fiscal year 2024. These include TAK-279 for the treatment of psoriasis and psoriatic arthritis, TAK-861 for the treatment of narcolepsy type, soticlestat for the treatment of Lennox-Gastaut syndrome and Dravet syndrome, and fazirsiran for the treatment of 1-antitrypsin associated liver disease.

Mezagitamab previously received Orphan Drug Designation for the treatment of ITP from the U.S. Food and Drug Administration. The program recently received Fast Track Designation.

Chinwe Ukomadu, Head of the Gastrointestinal & Inflammation Therapeutic Area Unit at Takeda, said, "These Phase 2 results demonstrate mezagitamab's compelling disease modifying mechanism of action, which has the potential to achieve disease remission for people with ITP. There remains considerable unmet need among ITP patients who may not respond or have inadequate response to prior treatment. In addition, some patients who do respond to available therapies struggle to manage side effects or relapse despite treatment."

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