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ORYZON Enrolls First Patient in EVOLUTION, a Phase IIb Clinical Trial With Vafidemstat in Schizophrenia

  • Primary objectives: to assess the effect of vafidemstat to address negative and cognitive symptoms in schizophrenia
  • Phase IIb adaptive trial planning to enroll 100 patients
  • Second Phase IIb study of vafidemstat in CNS disorders

Excerpt from the Press Release:

MADRID, Spain and CAMBRIDGE, Mass., Nov. 17, 2021 (GLOBE NEWSWIRE) — Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today the enrollment of the first patient in the EVOLUTION Phase IIb clinical trial with vafidemstat in patients with schizophrenia, at the Vall d’Hebrón Hospital in Barcelona, Spain.

EVOLUTION (EudraCT No.: 2021-000350-26) is a multicenter, double-blind, randomized, placebo-controlled, 24-week Phase IIb trial to evaluate the efficacy and safety of vafidemstat in adult schizophrenia patients under stable antipsychotic therapy. The trial has two primary independent objectives: to assess the effect of vafidemstat on negative symptoms of schizophrenia, and to assess improvement on cognitive impairment associated with schizophrenia (CIAS). To accommodate this second ambitious primary objective, patients will be treated for 6 months. EVOLUTION includes multiple primary and secondary endpoints focusing on negative and positive symptoms, as well as cognition. The trial will be conducted in 6-10 sites in Spain and aims to include 100 patients in total, with 50 patients in each arm. An interim analysis is foreseen to adjust the final number of patients needed to assess efficacy.

Oryzon’s Chief Medical Officer for CNS, Dr. Michael Ropacki, said: “We are excited for the first patient in (FPI) in EVOLUTION, our Phase IIb trial focused on the negative symptoms and cognitive impairments associated with schizophrenia. Considering the significant side effect profiles of atypical antipsychotics used to treat schizophrenia, vafidemstat holds tremendous potential to be a safe, effective, and well-tolerated treatment option to treat the underlying cognitive dysfunction and negative symptoms of schizophrenia.”

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