Nuvelution Pharma announced the initiation of patient enrollment in the Phase II/III (ARTISTS 1) trial of AUSTEDO (deutetrabenazine) to investigate the treatment of tics associated with Tourette syndrome in pediatric patients.
AUSTEDO was approved by the U.S. FDA for the treatment of chorea associated with Huntington’s disease in April 2017 and for tardive dyskinesia in adults in August 2017. Teva and Nuvelution signed a partnership agreement in September 2017 to advance AUSTEDO through clinical testing in pediatric Tourette syndrome patients and the corresponding regulatory submissions.
“Given the lack of available treatment options for pediatric patients affected with this disorder, Nuvelution is pleased to be working with Teva in the evaluation of AUSTEDO for the treatment of tics associated with Tourette syndrome. We are excited about the progress of our program and the initiation of the Phase II/III trial, which attest to our teams working well in concert,” said Sandy Zweifach, CEO & President of Nuvelution Pharma, Inc.
Under the partnership, Nuvelution will fund and manage clinical development, driving all operational aspects of the Phase II/III clinical development program. Teva will lead the regulatory process and be responsible for commercialization. If the FDA approves AUSTEDO for Tourette syndrome, Teva will pay Nuvelution a pre-agreed return on its invested capital.
AUSTEDO was previously granted Orphan Drug Designation by the U.S. FDA for the treatment of Tourette syndrome in the pediatric population.
Tourette syndrome is a neurological disorder characterized by repetitive, stereotyped, involuntary movements and vocalizations called tics. The early symptoms of Tourette syndrome are typically noticed first in childhood, with the average onset between the ages of 3 and 9 years. Although Tourette syndrome can be a chronic condition with symptoms lasting a lifetime, most people with the condition experience their worst tic symptoms in their early teens, with improvement occurring in the late teens and continuing into adulthood.
This study is a multicenter, randomized, double-blind, placebo-controlled, Phase II/III study to evaluate the safety, tolerability and efficacy of AUSTEDO (deutetrabenazine) in up to 100 pediatric patients with moderate to severe Tourette syndrome. Patients will receive either AUSTEDO or placebo using a 1:1 randomization over 12 weeks of dosing. The primary endpoint is the change in the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS) from baseline to week 12 between placebo and active treatment groups. Tourette symptoms will also be evaluated using Clinical and Patient Global Impression Scales.
AUSTEDO is a vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the FDA for the treatment of tardive dyskinesia in adults and for the treatment of chorea associated with Huntington’s disease. Safety and effectiveness in pediatric patients have not been established.