Castres, France, February 3, 2015 / B3C newswire / - Pierre Fabre Pharmaceuticals announce 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.
Schizophrenia is a chronic psychiatric disorder that affects approximately one percent of the adult population, and is usually diagnosed between the ages of 15 and 35 years. Schizophrenia is defined as a mental disorder characterized by abnormalities in one or more of the following five symptomatic domains: delusions, hallucinations (auditory hallucinations are the most common), disorganized thinking, grossly disorganized or abnormal motor behavior (including catatonia), and negative symptoms including diminished emotional expression, avolition (the inability to undertake and pursue meaningful goals) and anhedonia (the inability to experience pleasure from normally enjoyable situations) as prominent symptoms. It is often accompanied by cognitive impairments such as attention deficit, memory loss and problems processing information and making decisions, which lead to significant social or occupational dysfunction.
About treatment of schizophrenia
Benchmark treatments are antipsychotics that block dopamine D2 receptors. Although the D2 receptor has long been considered as the major target for antipsychotics, all antipsychotics bind with similar affinity to D2 and D3 receptors, so that the role of D3 receptor is incompletely understood. Recent studies have, however, suggested that blockade of cortical D2 receptors may be detrimental to the cure of negative symptoms and could aggravate cognitive dysfunction by impairing dopamine functions. The D3 receptor is not expressed in the cortex, but rather in subcortical areas that participate to feedback and feed-forward loops that control the prefrontal cortex, a major location for dysfunctions in schizophrenia.
Pierre Fabre Laboratories' expertise in CNS
The company’s CNS focus aims at converting its pipeline into a range of CNS therapies that engage novel mechanisms of action for providing improvement in pathologies and symptomatic domains with unmet or major therapeutical needs. The Pierre Fabre Research Institute’s other development programs in CNS include:
- a program on functional recovery after a stroke, based on the use of levomilnacipran, a balanced serotonin and norepinephrine reuptake inhibitor. The study was conducted on 532 patients and the results are expected in Q1 2015;
- a program on osteoarthritis and cancer pain, based on the concomitant blockade of the receptors for Nerve Growth Factor and Brain-Derived Neurotrophic factor;
- a program for a Rapid-Acting Antidepressant Drug, based on N-methyl-D-aspartate receptor blockade;
- and several other early-stage programs targeting neuropathic pain and anxiety.
About Pierre Fabre Laboratories
Pierre Fabre is the 3rd largest French pharmaceutical group and the 2nd largest dermo-cosmetics laboratory in the world. In 2013, its sales reached €2.008 Billion, with Dermo-Cosmetics revenues accounting for 55% and international for 56%. Founded and its headquarters still based in the South-west of France, Pierre Fabre currently has branches in 44 countries and distribution agreements in over 130 countries.
Covering a continuum of healthcare products, from prescription drugs and consumer health care products (OTC, oral care, natural health) to dermo-cosmetics, Pierre Fabre Laboratories employ over 10,000 people worldwide. In 2013, Pierre Fabre allocated more than 17% of its drug revenues to R&D.
With brands such as Avène, Klorane, Ducray, René Furterer, A-Derma, Galénic, Naturactive, Elgydium, Eludril or Drill, Pierre Fabre Laboratories are market leaders when it comes to skin, hair and oral care products distributed in the French pharmacy channel. Avène Thermal Spring Water is marketed worldwide, and is the leading dermo-cosmetics brand sold in Europe, Japan and China. In oncology, Pierre Fabre achieves 90% of its revenues outside of its home country.
Through the Pierre Fabre Participations holding company, the Pierre Fabre Foundation, a government-recognized public-interest foundation, owns 86% of Pierre Fabre Laboratories. Remaining shares are owned by company employees, amounting to 7%, and through treasury stock.
The French certification group AFNOR has audited Pierre Fabre Laboratories for its corporate social responsibility (CSR) performance at advanced level (AFAQ 26 000)
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