Safety ConcernsThree patients were discontinued from the study: one patient in the low-dose group had a serious adverse event (SAE) of B-cell lymphoma, and two patients in the high-dose group had treatment-emergent adverse events such as pyrexia, tachycardia, pain, and pruritus.
Study ChallengesThe EryDex P3 study stems from a prior miss in another P3 (ATTeST) while with EryDel, indicating previous challenges in achieving primary endpoints.
Study ResultsThe ATTeST study missed on the primary endpoint of intent-to-treat modified International Cooperative Ataxia Rating Scale.