Takeda recently announced positive results from a phase 2 clinical trial of their investigational therapy (Mezagitamab), to treat patients with persistent or chronic primary immune thrombocytopenia (ITP). The therapy is developed with laboratory engineered monoclonal antibodies, which are cloned versions of human antibodies produced by the body’s immune system.
Primary ITP is a rare autoimmune disorder that causes a significant reduction in platelets, which are necessary for clotting. Symptoms of ITP include the appearance of petechiae (clusters of red spots where capillaries below the skin have bled), excessive bruising, nose bleeds and bleeding of the gums associated with dental procedures. In addition, women with ITP may experience heavier and prolonged menstrual bleeding. The disease can cause fatigue and impact quality of life. In the most severe cases, ITP can even become life-threatening.
The ongoing international study is evaluating Mezagitamab for safety, efficacy, and tolerability at three dose levels. These varying doses were given as subcutaneous injections. According to a new press release, an interim analysis showed overall positive safety efficacy results. It also demonstrated that Mezagitamab has been “generally safe and well tolerated” across all three dosing groups. The results also showed that a rapid boost in platelet counts occurred in all three groups, with the largest count achieved in the highest dose group. The company also reported that improvements in platelet counts, and functioning were largely sustained post-treatment.
“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,” said Chinwe Ukomadu, Head of the Gastrointestinal & Inflammation Therapeutic Area Unit at Takeda.
The company plans to initiate a phase 3 trial later this year.
Learn more about the trial.
Source: Takeda press release dated March 13, 2024
