Phase 3 trials of oral tavapadon in easing motor symptoms nearing end

Results of TEMPO program in early and late-stage Parkinson's due in 2024

Patricia Inácio, PhD avatar

by Patricia Inácio, PhD |

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An ongoing and global Phase 3 clinical trial program for oral tavapadon, a selective dopamine receptor agonist aiming to improve motor function in people with Parkinson’s disease, expects to release study findings next year.

Three separate, 27-week trials are evaluating tavapadon’s efficacy, safety, and tolerability against a placebo in recently diagnosed adults to those with advanced disease.

TEMPO-1 (NCT04201093) is investigating a fixed, 5 mg or 15 mg daily dose of tavapadon and TEMPO-2 (NCT04223193) flexible once daily doses of up to 15 mg; both involve people in the disease’s early stages. TEMPO-3 (NCT04542499) is assessing flexible 5 to 15 mg daily doses in late-stage Parkinson’s patients experiencing motor fluctuations while on levodopa treatment.

“Cerevel is bringing forward one of the broadest neuroscience pipelines in the industry, with novel approaches to treating challenging diseases, and we remain focused on execution as we head into multiple data readouts in 2024,” Ron Renaud, president and chief executive officer of Cerevel Therapeutics, the investigational treatment’s developer, said in an investor press release.

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Also underway is a Phase 3 open-label extension study called TEMPO-4 (NCT04760769,  EudraCT2019-002952-17), evaluating tavapadon’s long-term efficacy and safety in an estimated 1,200 patients, including those in placebo groups in the therapy’s main trials.

Results from the TEMPO-3 trial are expected by close of June, and those for TEMPO-1 and TEMPO-2 by the end of 2024, Cerevel announced. Both TEMPO-1 and 2 may still be enrolling eligible patients at sites across North America, Europe, and Australia, and in Israel for TEMPO-1.

Tavapadon is a type of dopamine receptor agonist, meaning that it mimics the action of dopamine, a chemical messenger involved in movement coordination that is progressively lost in Parkinson’s.

Low dopamine levels underlie the key symptoms of Parkinson’s disease, such as tremors, slowness of movement, rigidity, and gait and balance problems.

Findings an earlier, 15-week Phase 2 trial (NCT02847650) in 57 people with early stage Parkinson’s showed that treatment with tavapadon eased their motor symptoms.

In the main Phase 3 trials, patients randomized to treatment who are in early disease stages — those diagnosed with Parkinson’s less than three years ago and who are not, or only rarely, using levodopa — are given tavapadon alone, whereas those with late-stage Parkinson’s will be given tavapadon as an add-on to a stable levodopa dose.

Open-label extension study is following three main Phase 3 trials

TEMPO-1 and TEMPO-2 aim to assess changes in motor function using the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II and III combined scores. TEMPO-3 focuses on investigating whether tavapadon added to levodopa lowers a patient’s daily on time with problematic dyskinesia, the uncontrolled movements associated with long-term levodopa use.

On time refers to periods when the medication effectively manages Parkinson’s motor symptoms, as opposed to off episodes.

Patients who complete any of the TEMPO main trials can join the extension study, evaluating the safety and effectiveness of tavapadon given at a flexible 5 to 15 mg dose for 58 weeks, or about 13 months. Those using levodopa will continue so for the trial’s duration.

Tavapadon is designed to bind selectively to dopamine D1 and D5 receptors on the surface of nerve cells, aiming to “maximize motor benefit while reducing the prolonged receptor overexcitation and desensitization caused by full agonists, which can lead to dyskinesias,” Cerevel reports.