Madrid and Cambridge, Mass. — August 25, 2025 — Leads & Copy — Oryzon Genomics, S.A. (ORY), a biopharmaceutical company specializing in epigenetics, announced that the European Medicines Agency (EMA) has approved its Clinical Trial Application (CTA) to begin a Phase Ib trial of iadademstat in sickle cell disease (SCD).
The trial, named RESTORE, will enroll 40 adult patients with SCD across multiple sites in Spain. It will assess the safety, tolerability, and optimal dosage of iadademstat, while also evaluating its ability to induce fetal hemoglobin (HbF).
SCD, a chronic inherited blood disorder, affects millions worldwide and has limited therapeutic options. Iadademstat, an LSD1 inhibitor, has shown promise in preclinical studies by significantly increasing HbF levels, which could mitigate the disease’s pathological effects.
The SCD treatment market is expected to grow substantially, reaching approximately USD 8 billion by 2032. Oryzon is also investigating Iadademstat in multiple oncology clinical trials.
Dr. Ana Limón, Senior Vice-president of Clinical Development and Medical Affairs at Oryzon.
Contact:
Patricia Cobo/Mario Cordera, Atrevia, +34 91 564 07 25, pcobo@atrevia.com
Emili Torrell, Chief BD Officer, +34 673 33 97 65, etorrell@oryzon.com
Sandya von der Weid, LifeSci Advisors, LLC, +41 78 680 05 38, svonderweid@lifesciadvisors.com
Source: Oryzon Genomics, S.A.
