Add-on tavapadon eases symptoms in late Parkinson’s, data show

Two hands, a stethoscope, and a handful of oral medications surround a graph labeled "clinical trial" in capital letters.

Six months of daily tavapadon, as an oral add-on therapy to standard levodopa, significantly increased on time without troublesome dyskinesia, or involuntary body movements, in people in the late stages of Parkinson’s disease, according to top-line data from a Phase 3 study.

Data from the trial, dubbed TEMPO-3 (NCT04542499), will be presented at a future medical meeting and support approval submissions to regulatory authorities, the therapy’s developer, Cerevel Therapeutics, announced in a company press release.

Tavapadon is also being tested as a single therapy in early-stage Parkinson’s in TEMPO-1 (NCT04201093) and TEMPO-2 (NCT04223193), with data expected in the second half of this year.

“We are highly encouraged with the results announced today, and look forward to sharing additional data later this year from the monotherapy trials, TEMPO-1 and TEMPO-2, as we seek to evaluate tavapadon’s potential benefit to people living with Parkinson’s disease,” said Raymond Sanchez, MD, chief medical officer at Cerevel.

Parkinson’s is marked by the progressive loss of dopamine, a chemical messenger that plays a role in movement coordination. Low dopamine levels trigger the onset of Parkinson’s symptoms, such as tremors, rigidity, slowness of movement, and gait and balance problems.

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‘Significant need’ for new treatment

Levodopa, a precursor molecule that is converted to dopamine in the brain, is the standard Parkinson’s treatment. However, its long-term use can cause sudden, involuntary movements, or dyskinesia.

“Parkinson’s disease is the fastest growing neurodegenerative disorder in the world, and a significant need exists for a new treatment option that provides the right balance of dopamine signaling and delivers sustained motor control without the burdensome side effects associated with current treatments,” said trial principal investigator Hubert H. Fernandez, MD, a professor of neurology and director at the Center for Neurological Restoration at Cleveland Clinic.

Tavapadon is a dopamine agonist that binds to dopamine D1 and D5 receptors on the surface of nerve cells. By mimicking the action of dopamine, the therapy aims to help balance motor control.

“Tavapadon’s novel mechanism of action, which selectively activates the D1/D5 dopamine receptors, has demonstrated the potential to provide people living with Parkinson’s disease the right balance of motor control, safety and tolerability,” Sanchez said.

Data from a 15-week Phase 2 trial (NCT02847650) in 57 people with early-stage Parkinson’s showed that tavapadon alone safely and effectively reduced motor symptoms.

The now-complete TEMPO-3 evaluated the efficacy, safety, and tolerability of tavapadon as an add-on therapy to levodopa for advanced Parkinson’s. The trial enrolled 507 adults, ages 40-80, with Parkinson’s who were experiencing motor fluctuations.

Participants were assigned randomly to flexible 5 to 15 mg daily doses of tavapadon plus levodopa or placebo plus levodopa for 27 weeks, or 6.2 months.

The study’s primary goal was to increase the total on time – the period when medication effectively controls Parkinson’s symptoms –  without troublesome dyskinesia, based on the two-day average of a self-completed home diary used to assess motor function status.

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Effects on off time, other symptoms

Key secondary outcomes included a change in total daily off time, when symptoms are not fully controlled, and a change in the severity of motor and nonmotor symptoms, as indicated by the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts 1, 2, and 3.

Top-line data showed that adding tavapadon to levodopa significantly outperformed levodopa alone by increasing the total on time without troublesome dyskinesia by 1.1 hours (1.7 vs. 0.6 hours), meeting the trial’s primary goal. A significant reduction in off time was also observed for those treated with add-on tavapadon, the company noted.

The therapy was reportedly well tolerated with a safe profile consistent with prior clinical trials. Adverse events were reported as mild to moderate in severity.

“The results from the TEMPO-3 trial are particularly exciting as they demonstrate that tavapadon has the potential to offer an important new option for individuals living with this chronic, debilitating disease,” Fernandez said.

Patients who completed TEMPO-1, TEMPO-2, and TEMPO-3 can enroll in TEMPO-4 (NCT04760769EudraCT2019-002952-17), a Phase 3 open-label extension study to test tavapadon’s efficacy and safety over a 58-week treatment period (about 13 months).

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