Pierre Fabre Pharmaceuticals announce initiation of Phase IIa clinical trial program for F17464 in schizophrenia
Posted: 3 February 2015 |
Pierre Fabre Pharmaceuticals has announced the initiation of a Phase IIa clinical trial program for F17464, a new selective dopamine D3 receptor antagonist, in schizophrenia. The trial is designed to assess the efficacy and safety of F17464 compared to placebo in patients with acute schizophrenia. The six-week multinational European trial will enroll 142 patients…
Pierre Fabre Pharmaceuticals has announced the initiation of a Phase IIa clinical trial program for F17464, a new selective dopamine D3 receptor antagonist, in schizophrenia. The trial is designed to assess the efficacy and safety of F17464 compared to placebo in patients with acute schizophrenia. The six-week multinational European trial will enroll 142 patients.
This development is a reflection of Pierre Fabre Laboratories’ strategy to invest in R&D on priority franchises such as neuropsychiatry, oncology and dermatology.
About F17464: Pierre Fabre Pharmaceuticals laboratories’ candidate medication, F17464, is a potent oral selective D3 antagonist/5-HT1A partial agonist. It is currently being developed for the treatment of schizophrenia.
“After the marketing authorization issued in 2013 by the FDA to Forest Laboratories, Inc. now Actavis, plc for Fetzima® -levomilnacipran an active compound discovered by the Pierre Fabre Research Institute ; we welcome this new step with another molecule from our R&D experts’ research into the central nervous system. The originality of this new molecule and the initial pharmacodynamics and safety results are extremely encouraging,” declared Frédéric Duchesne, President of Pierre Fabre Pharmaceuticals.
About the clinical trial: The Phase IIa clinical trial is a randomized, double-blind, placebo-controlled study assessing the efficacy and safety of one fixed daily dose of F17464 as an antipsychotic treatment in patients with a well-documented diagnosis of schizophrenia (according to the Diagnostic and Statistical Manual of Mental Disorders, DSM-IV-TR) and presenting a recent acute schizophrenic episode. The primary endpoint of the trial is the efficacy of F17464 on psychotic symptoms, as measured with the change from baseline on the Positive and Negative Syndrome Scale (PANSS) total score at the end of the six-week treatment period. Secondary endpoints include the assessment of the Clinical Global Impression scales (CGI-Severity and CGI-Improvement) and the Calgary Depression Scale for schizophrenia (CDSS). Safety will be determined by standard clinical and laboratory safety assessments and specific measures for extrapyramidal symptoms and suicidal risk scale.
