The company is tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Tavapadon is an orally-bioavailable, once-daily partial agonist that selectively targets dopamine D1/D5 receptor subtypes. It has been rationally designed with the goal of balancing meaningful motor control activity while minimizing the side effects typical of drugs that non-selectively stimulate dopamine.
'We are encouraged by the benefit-risk profile of tavapadon based on the efficacy results observed in Phase 2 trials, as well as the tolerability profile we have seen in our clinical program to date,' said
The Phase 3 program includes three 27-week, double-blind, randomized, placebo-controlled, parallel-group trials designed to evaluate the efficacy, safety and tolerability of fixed doses (TEMPO-1) and flexible doses (TEMPO-2) of tavapadon as a monotherapy in patients with early-stage Parkinson's disease or as an adjunctive therapy to levodopa in patients with late-stage Parkinson's disease who are experiencing motor fluctuations (TEMPO-3).
Approximately 1,200 patients ages 40 to 80 years will be enrolled across all three trials. The primary endpoint of the TEMPO-1 and TEMPO-2 trials is the change from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II and Part III combined score. The primary endpoint of the TEMPO-3 trial is the change from baseline in total daily 'on' time without troublesome dyskinesia. A fourth 58-week, open-label, safety extension trial will also be conducted as part of the program.
As the company's most advanced therapeutic program, tavapadon has been evaluated in 272 subjects in Phase 1 and Phase 2 trials, including in both early- and late-stage Parkinson's patient populations, which is required for a broad indication in Parkinson's disease. Across Phase 1b and Phase 2 trials conducted to date, tavapadon has demonstrated motor control benefit with the potential for an improved tolerability profile relative to D2/D3-preferring agonists.
Initiation of the registration-directed Phase 3 program for tavapadon began in
About Tavapadon
Tavapadon is a potent, orally-bioavailable, selective partial agonist of the dopamine D1 and D5 receptors. This investigational therapeutic is being evaluated for the once-daily symptomatic treatment of Parkinson's disease.
About Parkinson's Disease
Approximately 10 million people worldwide are living with Parkinson's disease, according to the
About
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