Nuvelution Pharma Announces Commencement of Patient Enrollment in Phase II/III Clinical Study of AUSTEDO® (deutetrabenazine) for the Treatment of Tourette Syndrome in Pediatric Patients
San Francisco, CA, February 28, 2018 – Nuvelution Pharma, Inc. today 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.
About Tourette Syndrome
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.
About the ARTISTS 1 Study
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 U.S. Food and Drug Administration 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.
Important Safety Information
AUSTEDO® can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyone considering the use of AUSTEDO® must balance the risks of depression and suicidality with the clinical need for treatment of chorea. AUSTEDO® is contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression.
AUSTEDO® is also contraindicated in: patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine (Xenazine®) or valbenazine (Ingrezza®).
AUSTEDO® may cause a worsening in mood, cognition, rigidity, and functional capacity in patients with Huntington’s disease. Tetrabenazine (a closely related VMAT2 inhibitor) causes an increase in the corrected QT (QTc) interval. A clinically relevant QT prolongation may occur in some patients treated with AUSTEDO® who are CYP2D6 poor metabolizers or are co-administered a strong CYP2D6 inhibitor or other drugs that are known to prolong QTc. Neuroleptic Malignant Syndrome has been observed in patients receiving tetrabenazine. AUSTEDO® may increase the risk of akathisia, agitation, and restlessness. AUSTEDO® may cause parkinsonism in patients with Huntington’s disease. Sedation is a common dose-limiting adverse reaction of AUSTEDO®.
The most common adverse reactions (4% of AUSTEDO®-treated patients and greater than placebo) in controlled clinical studies of patients with tardive dyskinesia were nasopharyngitis and insomnia. The most common adverse reactions (>8% of AUSTEDO®-treated patients and greater than placebo) in a controlled clinical study of patients with chorea associated with Huntington’s disease were somnolence, diarrhea, dry mouth, and fatigue.
Please click here for U.S. Full Prescribing Information, including Boxed Warning: austedo.com/hcp/pi.
About Nuvelution Pharma
Nuvelution leverages its extensive knowledge, experience and relationships in the pharma and biotech industries to deploy capital in risk-sharing collaborations with companies where product development can be facilitated by both capital and human resources with the goal of making this model an essential tool for pharma and biotech companies to bring products to the market. For more information, please visit www.nvtpharma.com.
Contacts Nuvelution Pharma, Inc. Sandy Zweifach, 650-866-8065