Link Securities | Oryzon Genomics (ORY) announced that the European Medicines Agency (EMA) has approved its Clinical Trial Authorisation (CTA) application to initiate a Phase II study with iadademstat in patients with essential thrombocythaemia (ET), thus expanding the clinical development of the drug beyond acute leukaemia to other haematological indications, according to the Bolsamanía website.
The study, called IDEAL (Iadademstat treatment for Essential Thrombocythaemia), will be a multicentre, open-label, single-arm trial conducted in Spain in adult patients with ET who are resistant or intolerant to hydroxyurea, the standard first-line treatment. The primary objectives of the trial will be to evaluate the safety and tolerability of iadademstat, as well as to determine its efficacy in reducing the percentage of patients with abnormal platelet counts. Secondary objectives include the durable haematological response rate, confirmation of the drug’s pharmacokinetic and pharmacodynamic profile, and the duration of haematological remissions.
