Cerevel Therapeutics, a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, announced that the first participants have been dosed in all three of the clinical trials in their phase 3 programme evaluating tavapadon in patients with Parkinson’s disease. 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 Raymond Sanchez, M.D., chief medical officer of Cerevel Therapeutics. “We look forward to advancing the development of tavapadon and potentially bringing a differentiated, cornerstone therapy to Parkinson’s patients at all stages of the disease as supported by a robust phase 3 programme.”The phase 3 programme 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 programme for tavapadon began in January 2020. In response to the COVID-19 pandemic, Cerevel Therapeutics paused screening and enrollment in all trials in March 2020 and has remained vigilant about participant safety and data integrity. Now that the program is resuming, the company expects preliminary data readouts in the first half of 2023.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.Approximately 10 million people worldwide are living with Parkinson’s disease, according to the Parkinson’s Foundation. The disease is characterized by a progressive degeneration of dopaminergic neurons (the main source of dopamine) leading to a loss of critical motor and non-motor functions. Symptom severity and disease progression differ between individuals but typically include slowness of movement (bradykinesia), trembling in the extremities (tremors), stiffness (rigidity), cognitive or behavioral abnormalities, sleep disturbances and sensory dysfunction. There is no laboratory or blood test for Parkinson’s disease, so a diagnosis is made based on clinical observation, which may contribute to an underestimation of the incidence of the disease.
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