July 1, 2015. Avineuro LLC announced completion of phase II pilot clinical study of AVN-211, a proprietary orally-bioavailable molecule of a 5-HT6 receptor antagonist. In a multicenter double-blind randomized placebo-controlled pilot study of efficacy and safety of AVN-211 for amplifying the effects of antipsychotic drugs in patients with schizophrenia in a condition of incomplete remission receiving stable antipsychotic therapy, 80 patients were randomized to receive 8 mg of AVN-211 or Placebo QD for 6 weeks (initial dose 4 mg of AVN-211 was prescribed QD for 1 week following dose ascending up to 8 mg QD for 5 weeks or equivalent Placebo). The drug was safe and well-tolerated, no serious adverse effects were reported. Although there were no statistically significant difference between the groups in primary efficacy endpoint, patients on atypical antipsychotics demonstrated the tendency of superiority over Placebo in mean reduction of PANSS General score and Positive scale score. These results support the assumption of AVN-211 mode of action and synergetic antipsychotic effect of 5-HT6 inhibitors in patients receiving atypical antipsychotics. Thus it has been suggested that AVN-211 should be further investigated specifically in larger population of schizophrenic patients in incomplete remission receiving stable antipsychotic therapy with atypical antipsychotics for demonstrating amplification of the antipsychotic effect.

Avineuro LLC plans to continue clinical trials AVN-211 as adjuvant therapy in patients with schizophrenia in partial remission and adjuvant therapy of symptomatic treatment in patients with mild-moderate Alzheimer’s disease.



Alena Ivachtchenko, MBA

Director, Business Development

Avineuro Pharmaceuticals, Inc.