Cerevel Therapeutics Announces Positive Topline Results for Tavapadon in Phase 3 Adjunctive Trial for People Living with Parkinson’s Disease - Seite 2

Full results from the TEMPO-3 study will be submitted for presentation at future medical meetings and used to support regulatory submissions of tavapadon as a treatment for Parkinson’s disease. Topline results from the Phase 3 monotherapy trials for tavapadon, TEMPO-1 and TEMPO-2, are expected in the second half of 2024.

About TEMPO Clinical Development Program

The TEMPO clinical development program is evaluating the efficacy, safety and tolerability of tavapadon across a broad Parkinson’s population, including two monotherapy Phase 3 trials (TEMPO-1 and TEMPO-2) and one adjunctive Phase 3 trial (TEMPO-3). Cerevel is also conducting a fourth, open-label extension (OLE) trial (TEMPO-4) to assess the long-term safety and tolerability of tavapadon.

TEMPO-3 was a Phase 3 double-blind, randomized, placebo-controlled, parallel-group, flexible-dose, 27-week trial to evaluate the efficacy, safety and tolerability of tavapadon as an adjunctive therapy to LD for advanced Parkinson's disease. Patients were provided with a home diary to assess their motor function status (Hauser diary). The primary endpoint was change from baseline in the total “on” time without troublesome dyskinesia based on the two-day average of the self-completed Hauser diary. Key secondary endpoints included change from baseline in total daily “off” time, change from baseline in total “on” and “off” time at earlier timepoints in the trial, and change from baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I, II and III Scores.

A total of 507 adults between the ages of 40-80 were enrolled in the trial. All had a confirmed diagnosis of Parkinson’s disease, were experiencing motor fluctuations and were on a stable dose of LD for at least 4 weeks prior to screening. Patients were randomized to receive either tavapadon adjunctive to LD, titrated to 5-15 milligrams, or placebo and LD, orally and once-daily.

More information on the trial can be found on www.clinicaltrials.gov (NCT04542499).

About Tavapadon

Tavapadon is the first and only selective D1/D5 receptor partial agonist in development for Parkinson’s disease and is currently being studied as a once-daily medicine for use as both a monotherapy and as an adjunctive therapy to LD. Tavapadon is designed to selectively and optimally activate D1/D5 receptors to potentially provide the right balance of motor control, safety and tolerability for patients. By selectively activating D1/D5 dopamine receptors along the nigrostriatal pathway, tavapadon has the potential to offer the right balance of dopamine signaling to improve motor control while avoiding D2/D3 overstimulation, which is believed to underlie many of the side effects of current dopamine agonists. Additionally, as a partial agonist with a 24-hour half-life enabling once-daily dosing, tavapadon may avoid hyperactivation of the dopamine receptors, which can lead to troublesome dyskinesias.^1,2