Positive results for EnVivo's EVP-6124

Massachusetts, USA-based EnVivo Pharmaceuticals says that findings from its safety and biomarker study for EVP-6124, a potent specific alpha-7  agonist, showed significant improvement in sensory processing and  cognition biomarkers in subjects with schizophrenia (Marketletter April  14, 2008). Specific biomarkers included the p300 response, Mismatch  Negativity, 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, the firm noted.

"These results are extremely encouraging," said 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, USA. "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," he added.

These data support the safety and potential efficacy of EVP-6124 in this  patient population, according to the company. 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 is planning to perform larger Phase II  proof-of-concept studies this year to further demonstrate the safety and  efficacy of EVP-6124.