A mid-stage trial on Takeda’s anti-CD38 therapy, mezagitamab, has demonstrated the drug’s potential to boost platelet counts in patients with immune thrombocytopenia (ITP).
In the Phase II study (NCT04278924), patients received a once-weekly, subcutaneous dose of either placebo or 100mg, 300mg or 600mg of mezagitamab for eight weeks. Adults enrolled on this trial all had chronic or persistent ITP, with patients having received four prior ITP treatments on average. The primary endpoint centred around the drug’s safety.
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During the trial, 19 out of 28 patients (68%) given mezagitamab experienced an adverse event (AE), while nine of 13 (69%) faced the same outcome in the placebo arm. Of the patients who had at least one AE during the trial, five (18%) and three (23%) experienced an AE rated Graded 3 or higher in the mezagitamab and placebo arms, respectively.
Alongside its reasonable tolerability, a 600mg dose of mezagitamab triggered a platelet response in 10 out of 11 (91%) patients, compared with three (23%) in the placebo group.
Following the positive results of this mid-stage study, Takeda is exploring the potential of mezagitamab in ITP through a Phase III trial (NCT06722235). The company estimates that the study will reach primary completion at the end of 2027, according to ClinicalTrials.gov.
The Tokyo-based pharma company is also evaluating the CD38-targeting monoclonal antibody (mAb) in a Phase III study in immunoglobulin A nephropathy (IgAN), as the drug triggered a sustained positive impact on kidney function 18 months in a Phase Ib, open-label study (NCT05174221).
ITP landscape undergoes a shift
While targeted therapies have reached the ITP market in recent years, researchers estimate that approximately 20% of patients with ITP do not benefit from available therapies.
This has led several companies to develop and commercialise drugs with novel mechanisms of action that can benefit patients with this disease.
Recently, Sanofi’s Wayrilz (rilzabrutinib) became the first Bruton’s tyrosine kinase (BTK) inhibitor to secure approval in ITP, which addresses the root case of the disease through its multi-faceted immune modulation capabilities. A consensus forecast from GlobalData, parent company of Clinical Trials Arena, forecasts that Wayrilz will pull in sales of $704m in 2032.
Meanwhile, Sobi recently secured a label expansion for its thrombopoietin receptor agonist, Doptelet (avatrombopag), meaning the drug can now be used in ITP patients aged one year and up.
Novartis’ ianalumab also demonstrated its potential in ITP in the Phase III VAYHIT2 study (NCT05653219), with the Swiss pharma planning to submit data to regulators for the drug in 2027.
