Cerevel Therapeutics Initiates Phase 3 Program Testing Tavapadon for Improved Motor Function

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by Forest Ray PhD |

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FHL-301 trial being planned

Cerevel Therapeutics announced its launch of a series of Phase 3 clinical trials to evaluate its investigational therapy tavapadon, designed to improve motor function in people with Parkinson’s disease.

The company will conduct three 27-week trials to evaluate tavapadon’s efficacy, safety, and tolerability in fixed doses — TEMPO-1 (NCT04201093) — and flexible doses — TEMPO-2 (NCT04223193) and TEMPO-3 (not yet assigned an NCT number). Cerevel also will conduct a fourth 58-week, open-label, safety extension trial.

TEMPO-1 and TEMPO-2 are currently recruiting participants at a single site in south Florida. More information on enrollment can be found here and here. TEMPO-3 will begin screening prospective participants later this year.

Tavapadon is a dopamine receptor agonist, meaning that it connects with dopamine receptors on the surface of nerve cells to make them act as though dopamine were present. This is vital in treating Parkinson’s, as the disease’s defining feature is the death of dopamine-producing (dopaminergic) neurons. Dopamine is a neurotransmitter that plays a key role in coordinating movement, which is why its loss results in the motor control problems seen in Parkinson’s.

In its Phase 2 trial (NCT02847650), Tavapadon successfully eased motor symptoms in and was well-tolerated by patients with early stage Parkinson’s. The results showed that the 57 participants, ages 45 to 80, lowered their scores — indicating improvement — on the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III for motor function over the course of 15 weeks.

The upcoming Phase 3 trials will further test tavapadon’s ability to improve motor function, evaluating the therapy in more patients and over a longer period of time. Cerevel intends to enroll approximately 1,200 patients, ages 40 to 80, across all three trials.

For the TEMPO-1 and TEMPO-2 studies, Cerevel is seeking participants with early stage Parkinson’s, while people with late-stage disease, who are experiencing motor fluctuations on levodopa treatment, will be recruited for the TEMPO-3 trial. Early-stage patients will receive tavapadon alone, whereas those with late-stage Parkinson’s will be given the therapy alongside levodopa.

TEMPO-1 participants will receive a single daily oral dose of up to 5mg of tavapadon. TEMPO-2 and TEMPO-3 participants will receive between 5 mg and 15 mg on a flexible dosing schedule.

All three trials will be placebo-controlled. The primary goal of TEMPO-1 and TEMPO-2 is changes in motor function as assessed by MDS-UPDRS parts II and III. Secondary goals include safety, improvement in non-motor aspects of daily living, reduction in disease severity, lessening of daytime sleepiness, and improvements in participant-reported outcomes as measured by the Patient Global Impression of Change (PGIC) score.

The company expects to begin reporting data from the studies in the second half of 2022.

“We believe tavapadon has the potential to improve outcomes for patients with both early-stage and late-stage Parkinson’s. It is our expectation that the innovative design of each of these Phase 3 trials will allow us to demonstrate tavapadon’s ability to improve patients’ motor symptoms and functioning,” Raymond Sanchez, MD, chief medical officer of Cerevel Therapeutics, said in a press release.