Cerevel Therapeutics (Nasdaq: CERE) has released encouraging findings from its pivotal Phase 3 TEMPO-3 trial for tavapadon, a unique D1/D5 receptor partial agonist investigated as a once-daily treatment for Parkinson’s disease. This trial assessed tavapadon’s efficacy, safety, and tolerability as an adjunctive therapy to levodopa (LD) in adults. The primary endpoint, demonstrating a significant increase of 1.1 hours in total “on” time without troublesome dyskinesia compared to LD and placebo (1.7 hours vs. 0.6 hours, p <0.0001), was met. Additionally, a notable reduction in “off” time, the key secondary endpoint, was observed in the tavapadon treatment group.
Dr. Raymond Sanchez, Chief Medical Officer at Cerevel Therapeutics, highlighted tavapadon’s selective activation of D1/D5 dopamine receptors, suggesting its potential to offer effective motor control with improved safety and tolerability for Parkinson’s patients. The positive results from TEMPO-3 are promising, with further data expected later this year from the TEMPO-1 and TEMPO-2 monotherapy trials.
The safety profile of tavapadon in the TEMPO-3 trial remained consistent with previous studies, with most adverse events being mild to moderate. Dr. Hubert H. Fernandez, Global Principal Investigator, emphasized the urgent need for innovative treatments in Parkinson’s disease, emphasizing tavapadon’s potential as a significant new option for patients.
Full results from the TEMPO-3 study will be presented at upcoming medical meetings and will support regulatory submissions for tavapadon as a Parkinson’s treatment. Additionally, topline results from the Phase 3 monotherapy trials, TEMPO-1 and TEMPO-2, are anticipated in the latter half of 2024.
The TEMPO clinical development program includes tavapadon’s evaluation across various Parkinson’s populations, encompassing monotherapy and adjunctive therapy trials. TEMPO-3, a Phase 3 trial, involved 507 adults with confirmed Parkinson’s disease, assessing tavapadon’s efficacy over 27 weeks as an adjunct to LD.
Tavapadon, as a selective D1/D5 receptor partial agonist, offers a promising approach to addressing the complexities of Parkinson’s disease, aiming for optimal motor control while minimizing side effects. Parkinson’s disease, a chronic neurodegenerative disorder affecting millions worldwide, presents a pressing need for innovative treatments offering sustained efficacy and improved quality of life for patients.
