San Diego, CA – January 10st, 2018 – Avineuro Pharmaceuticals, Inc. reported today promising results of clinical Phase Ib trials on AVN-101, an orally bioavailable and safe multi-target drug candidate for the treatment of CNS diseases associated with memory loss, cognitive dysfunction, neurodegeneration, depression, and general anxiety.

Patients tolerated AVN-101 well in a wide range of doses: no adverse events were observed. Avineuro Pharmaceuticals, Inc. plans to start Phase II clinical trials with AVN-101 for treatment of generalized anxiety disorders later this year. (more…)

Avineuro Completed Phase II Clinical Study Of AVN-211, A Selective 5-HT6 Receptor Antagonist

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.

Contact:
Alena Ivachtchenko, MBA
Director, Business Development
Avineuro Pharmaceuticals, Inc.
www.avineuro.com
ei@avineuro.com
1-786-617-4449

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.

Contact:

Alena Ivachtchenko, MBA

Director, Business Development

Avineuro Pharmaceuticals, Inc.

www.avineuro.com

ei@avineuro.com

1-786-617-4449

San Diego, CA – February 21st, 20011 –

Avineuro Pharmaceuticals, Inc. reported today positive top-line results from a Phase 2a clinical proof of concept trial to assess AVN-211 as an augmentation therapy to improve cognition in schizophrenia patients. In a double blind trial in 50 patients stabilized on an atypical antipsychotic therapy, AVN-211 met the protocol criteria for positive results on the primary efficacy outcome measures. AVN-211, administered orally in the dose of 4 mg QD, was well tolerated and no adverse events were observed.

About AVN-211:
AVN-211 is a novel highly selective 5-HT6 receptor antagonist discovered and optimized on the company’s drug discovery 5-HT6 platform.

About Cognition impairment in Schizophrenia:
Cognition impairment in patients with schizophrenia is recognized by many psychiatrists as the very core of the dysfunction in this disease making it extremely difficult for patients to work, study and maintain a social lifestyle.

About Avineuro Pharmaceuticals, Inc.:
Avineuro discovers and develops novel small molecules for unmet medical needs in neurology and psychiatry. Avineuro emphasizes a rational approach to drug discovery that combines modern medicinal chemistry with streamlined pre-clinical and clinical development studies, thus allowing a fast transition to proof-of-concept product candidates.

Contact:
Alena Ivashchenko, MBA
Director of Business Development
Avineuro Pharmaceuticals, Inc.
6605 Nancy Ridge Drive
San Diego, CA 92121
Phone: 858-357-6627
ei@avineuro.com
www.avineuro.com