Cerevel Therapeutics announced positive topline results from its pivotal Phase 3 TEMPO-3 trial for tavapadon, the first and only D1/D5 receptor partial agonist being studied as a once-daily treatment for Parkinson?s disease. The TEMPO-3 trial evaluated the efficacy, safety and tolerability of tavapadon as an adjunctive therapy to levodopa (LD) in adults. The trial met its primary endpoint ?

patients treated with tavapadon adjunctive to LD experienced a clinically meaningful and statistically significant increase of 1.1 hours in total ?on? time without troublesome dyskinesia compared to those treated with LD and placebo (1.7 hours vs. 0.6 hours, p <0.0001).

A statistically significant reduction in ?off? time, the key secondary endpoint, was also observed for the tavapadon treatment arm. 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. 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.