ORYZON receives approval to start EVOLUTION Phase IIb trial with vafidemstat in schizophrenia
Excerpt from the Press Release:
MADRID, Spain and CAMBRIDGE, Mass., July 13, 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 that it has received approval from the Spanish Drug Agency (AEMPS) for its Clinical Trial Application (CTA) to conduct a Phase IIb clinical trial with vafidemstat in patients with schizophrenia.
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. To accommodate this second ambitious primary objective, patients will be treated for 6 months. The trial 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.
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