ENVIVO REPORTS POSITIVE RESULTS OF ITS EVP-6124 CLINICAL BIO-MARKER STUDY IN SCHIZOPHRENIA PATIENTS
Effects on safety, pharmacokinetics, and biomarkers in subjects on long term stable atypical antipsychotic therapy comprise study's findings
WATERTOWN, MA, JANUARY 12, 2009 - EnVivo Pharmaceuticals today announced that findings from its safety and bio-marker study for EVP-6124, a potent specific alpha-7 agonist, showed significant improvement in sensory processing and cognition bio-markers in subjects with schizophrenia. Specific bio-markers included the p300 response, Mismatch Negativity (MMN), N100 response and p50 response. These evoked response biomarkers are measures of sensory processing and cognition that correlate with the degree of impairment of awareness, cognition and judgment as well as the overall clinical condition of patients with schizophrenia. Positive effects were also seen on several domains of the CogState computerized cognition test battery.
"These results are extremely encouraging," said Dr. Sheldon Preskorn, professor of psychiatry at the Kansas University School of Medicine-Wichita and the principal investigator at the Clinical Research Institute in Wichita, Kansas. "Although psychotic symptoms are reasonably well treated with current medications, a majority of patients with schizophrenia continue to suffer from the cognitive impairment associated with schizophrenia. Potential drugs such as EVP-6124 hold great promise in potentially alleviating some of these burdens for our patients. We are looking forward to the next trial based on these exciting positive results."
This Phase 1b, placebo-controlled, randomized study in chronic stable schizophrenic subjects on long-term atypical antipsychotic therapy was conducted in mid-2008 at the Clinical Research Institute in Wichita, Kansas. The study assessed the safety and tolerability of EVP-6124 as well as its effect on electrophysiological biomarkers. A total of 20 subjects were treated with either placebo or low or high dose EVP-6124 for a total of 21 days. Both doses of EVP-6124 were well tolerated with no clinically significant adverse events reported during treatment.
EVP-6124 is a selective agonist for the α7 subtype of the nicotinic acetylcholine receptor and is being developed by EnVivo Pharmaceuticals for potential cognitive enhancement in both schizophrenia and Alzheimer's disease. It has been shown to have excellent CNS penetration, oral bioavalaibility, pharmacokinetics and metabolic profile. A majority of patients with schizophrenia have substantial residual clinical deficits including cognitive dysfunction in spite of therapy with either typical or atypical antipsychotic drugs. These deficits affect thinking and prevent many patients from employment and leading productive lives.
These data support the safety and potential efficacy of EVP-6124 in this patient population. The effects on the evoked response biomarkers demonstrate that EVP-6124 accesses the central nervous system and has potentially biologically significant effects, including cognitive enhancement in subjects with Schizophrenia. Based on these encouraging results, EnVivo Pharmaceuticals is planning to perform larger Phase 2 proof-of-concept studies in 2009 to further demonstrate the safety and efficacy of EVP-6124.
About EnVivo Pharmaceuticals
EnVivo Pharmaceuticals, located in Watertown, Mass., is a biopharmaceutical company dedicated to discovering and developing small molecule therapeutics for disorders of the central nervous system, with current focus on Alzheimer's disease <http://www.envivopharma.com/template/2_21_20.html> , Huntington's disease <http://www.envivopharma.com/template/2_22_20.html> , cognition and schizophrenia. The company's lead product is an alpha-7 nicotinic acetylcholine receptor agonist for cognition disorders in Alzheimer's disease and schizophrenia. The company's preclinical development pipeline includes an epigenetics program based on Histone Deacetylase inhibition (HDACi) for cognition in Alzheimer's disease, a Gamma Secretase Modulator and a PDE10 inhibitor. For more information about EnVivo, visit www.envivopharma.com <http://www.envivopharma.com/> .