ORYZON Receives European Medicines Agency Approval to Initiate a Phase II Study of iadademstat in Essential Thrombocythemia
Excerpt from the Press Release:
MADRID and CAMBRIDGE, Mass., Feb. 24, 2026 (GLOBE NEWSWIRE) — Oryzon Genomics, S.A. (ISIN Code: ES0167733015, Ticker: ORY), a clinical-stage biopharmaceutical company and a global leader in epigenetics, today announced that the European Medicines Agency (EMA) has authorized its Clinical Trial Application (CTA) to initiate a Phase II study of iadademstat, Oryzon’s potent and selective LSD1 inhibitor currently in clinical development in oncology and hematology, for the treatment of essential thrombocythemia (ET).
The study, named IDEAL (IaDademstat treatment for EssentiAL thrombocythemia), is a multicenter, single-arm Phase II study to be conducted in Spain in adult patients with ET who are resistant/intolerant to hydroxyurea. The primary objectives of the study are to evaluate the safety and tolerability of iadademstat and to assess its efficacy in reducing the percentage of adult ET patients with abnormal platelet counts. Secondary objectives include assessing the durable clinical hematologic response (DCHR) rate, confirming the pharmacokinetic and pharmacodynamic profile of iadademstat in ET patients, and evaluating the duration of hematologic remissions (DHRs).
Iadademstat will be administered for up to 24 weeks. An additional 24-week extension phase will be available for patients who are benefiting from treatment and who, in agreement with their physician, elect to continue in the study.
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