Teva Pharmaceuticals has announced that the 2 trials designed to assess its vesicular monoamine transporter 2 (VMAT2) inhibitor deutetrabenazine in the treatment of tics in pediatric patients with Tourette syndrome failed to meet their primary end points.1
The trials—the phase 2/3 ARTISTS 1 (n = 119) and phase 3 ARTISTS 2 (n = 158)—included 277 total patients, with ARTISTS 2 investigating both a high and low dose of deutetrabenazine. The agent, which has also been assessed in tardive dyskinesia, failed to reduce motor and phonic tics compared to patients administered placebo, as assessed by total tic score on the Yale Global Tic Severity Scale (YGTSS).
“The results of the trials are disappointing, especially as there is such an unmet need for this community of pediatric patients,” said Hafrun Fridriksdottir, PhD, MS, executive vice president, Global R&D, Teva, in a statement. “As we assess a path forward, Teva is especially grateful to the investigators, patients, and families who contributed to these studies for such an important patient population.”
According to Teva, recently received data revealed that the most commonly reported adverse event (AE) in the 2 studies were headache, somnolence, and fatigue. No new safety signals were identified that were inconsistent with the known safety profile of deutetrabenazine.
Deutetrabenazine was approved by the FDA in April 2017 as Austedo for the treatment of chorea associated with Huntington disease and for the aforementioned tardive dyskinesia treatment in adults in August 2017.
Despite this failure, the therapy has seen sustained success in other conditions. Last October, Teva presented data on deutetrabenazine at the 2019 Psych Congress, suggesting that the VMAT2 inhibitor is associated with long-term, persistent efficacy in treating tardive dyskinesia.
The data, which included a cohort of 343 patients who completed the ARM-TD and AIM-TD studies (treatment, n = 232; placebo, n = 111), showed that those treated over the course of 80 weeks achieved higher response rates compared to positive short-term study results. At Week 54 (n = 250), 48% of patients achieved ≥50% response, and 24% achieved ≥70% response. At Week 106 (n = 169), 55% of patients achieved ≥50% response, and 30% achieved ≥70% response. At Week 132 (n = 108), 61% of patients achieved ≥50% response, and 40% achieved ≥70% response.2
1. Teva Announces Registration Trials of Deutetrabenazine in Pediatric Patients with Tourette Syndrome Did Not Meet the Primary Endpoint [press release].Tel Aviv, Israel: Teva; Published February 19, 2020. businesswire.com/news/home/20200219005903/en. Accessed February 24, 2020.
2. Teva to Present New Data on AUSTEDO® (deutetrabenazine) Tablets at Psych Congress 2019 [press release]. Jerusalem, Israel, and Parsippany, NJ: Teva Pharmaceuticals; Published October 2, 2019. businesswire.com/news/home/20191002005195/en/Teva-Present-New-Data-AUSTEDO%C2%AE-deutetrabenazine-Tablets. Accessed February 24, 2020.