Cerevel Therapeutics has reported positive topline results from its Phase III TEMPO-3 clinical trial evaluating a once-a-day dose of tavapadon to treat Parkinson's disease.
Tavapadon is a D1/D5 receptor partial agonist.
The 27-week, parallel-group, flexible-dose, double-blind, randomised, placebo-controlled study assessed the efficacy, safety, and tolerability of tavapadon as an adjunctive treatment to levodopa (LD) in 507 adult patients aged 40-80 years.
Patients were given a home diary to evaluate their motor function status (Hauser diary), and change from baseline in the total 'on' time without troublesome dyskinesia based on the two-day average of the self-completed Hauser diary was the trial’s primary endpoint.
Change from baseline in total daily 'off' time, change from baseline in total 'on' and 'off' time at earlier timepoints, and change from baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I, II and III Scores were the key secondary endpoints.
According to the findings, patients treated with tavapadon in addition to LD experienced a 1.1 hour rise in total 'on' time without troublesome dyskinesia versus those on LD and placebo, meeting the primary endpoint.
Furthermore, a statistically significant reduction in total daily 'off' time, a key secondary endpoint, was observed in the tavapadon treatment group.
Tavapadon was well tolerated in the trial and aligned with the safety profile in previous clinical studies.
Furthermore, most adverse events reported in the trial were mild to moderate in severity.
Cerevel Therapeutics chief medical officer Raymond Sanchez said: “Tavapadon’s novel mechanism of action, which selectively activates the D1/D5 dopamine receptors, has demonstrated the potential to provide people living with Parkinson’s disease the right balance of motor control, safety and tolerability.
“We are highly encouraged with the results, and look forward to sharing additional data later this year from the monotherapy trials, TEMPO-1 and TEMPO-2, as we seek to evaluate tavapadon’s potential benefit to people living with Parkinson’s disease.”
