Cerevel Therapeutics has announced positive phase 3 results for tavapadon as a once-daily treatment for patients living with Parkinson’s disease (PD).
The TEMPO-3 trial has been evaluating the efficacy, safety and tolerability of tavapadon as an adjunctive therapy to levodopa (LD) in adults with PD.
PD is the second most common progressive neurodegenerative disease, which affects seven million people worldwide.
The double-blind, randomised, placebo-controlled study investigated tavapadon for 27 weeks in 507 adults between the ages of 40 and 80 years with a confirmed diagnosis of PD.
Tavapadon, currently the only selective D1/D5 receptor partial agonist in development for PD, is designed to activate the D1/D5 receptors to potentially provide the right balance of dopamine to improve motor control, safety and tolerability in patients.
The trial met both its primary and secondary endpoints after demonstrating a clinically meaningful and statistically significant increase of 1.1 hours in total ‘on’ time, without dyskinesia in patients treated with tavapadon adjunctive to LD, compared to those treated with LD and placebo, as well as a significant reduction in ‘off’ time.
Additionally, tavapadon was generally well tolerated, with no new safety concerns reported and consistent with prior clinical trials.
The company will submit full results from the TEMPO-3 study for presentation at future medical meetings, as well as to support regulatory submissions of tavapadon as a treatment for PD.
Full topline results from the two phase 3 monotherapy trials for tavapadon, TEMPO-1 and TEMPO-2 are also expected in the second half of 2024.
Raymond Sanchez, chief medical officer, Cerevel Therapeutics, commented: “We are highly encouraged with the results announced today and look forward to sharing additional data later this year from the monotherapy trials… as we seek to evaluate tavapadon’s potential benefit to people living with PD.”
Cerevel Therapeutics first acquired tavapadon from Pfizer in 2018 and the company entered into an agreement in December 2023 to be acquired by AbbVie .
The deal, worth around $8.7 billion, is expected to close in the middle of 2024 and will grant AbbVie access to several of Cerevel’s clinical-stage and preclinical candidates, which targeted neurological and psychiatric disorders. This includes tavapadon, which AbbVie said could become “a near-term complementary asset” to its neuroscience pipeline.