Cerevel Therapeutics on Thursday reported topline data from the Phase III TEMPO-3 trial, demonstrating that its investigational Parkinson’s disease therapy tavapadon can significantly improve the control of motor symptoms when used with levodopa.
At 27 weeks, patients on tavapadon plus levodopa saw a 1.7-hour increase in total “on” time without troublesome dyskinesia. In Parkinson’s disease, on time refers to periods of good symptom control, when patients can move and function properly. This effect was nearly three times greater in TEMPO-3 than patients who were given placebo on top of levodopa, in whom this measure improved by only 0.6 hours.
The treatment effect of 1.1 hours was “clinically meaningful and statistically significant,” with a p-value less than 0.0001, according to Cerevel.
Tavapadon treatment also resulted in significantly lower “off” time, which refers to periods when medication is starting to wear off and symptoms become more noticeable and difficult. In the trial, tavapadon was also safe and well-tolerated, with most of its side effects being mild or moderate in severity.
Cerevel CMO Raymond Sanchez in a statement said that the company is “highly encouraged” by TEMPO-3’s results, which he added has shown that tavapadon has “the potential to provide people living with Parkinson’s disease the right balance of motor control, safety and tolerability.” Data from Thursday’s readout will support regulatory submissions for tavapadon, according to Cerevel.
Tavapadon is a potentially first-in-class selective partial agonist of the D1/D5 receptors, which are dopamine receptor subtypes that directly regulate motor activity, according to Cerevel’s website. This mechanism of action allows tavapadon to specifically activate the brain’s motor pathways while minimizing side effects such as sleepiness, sedation, hallucinations and impaired impulse control.
Significantly, tavapadon maximizes the activation of D1/D5 receptors while avoiding prolonged hyper-excitation, which typically leads to dyskinesias and “off” time.
Cerevel is currently testing tavapadon the Phase III TEMPO clinical development program. The late-stage trial is an adjunctive study and is designed to evaluate tavapadon when combined with levodopa. Cerevel is also assessing the candidate as a monotherapy in the TEMPO-1 and TEMPO-2 studies, data from which are expected to come out in the second half of this year.
TEMPO-4, meanwhile, will evaluate the long-term safety and tolerability of tavapadon.
Thursday’s readout comes just four months after AbbVie in December 2023 dropped $8.7 billion to acquire Cerevel and its pipeline assets targeting various neurology and psychiatric indications. The deal is expected to close by mid-2024.
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