In the TEMPO-1 trial, both tavapadon doses effectively reduced motor symptoms in patients with early-stage Parkinson's disease.
AbbVie announced positive topline results from its pivotal phase three TEMPO-1 trial evaluating tavapadon as a standalone treatment for early-stage Parkinson’s disease (PD), according to a news release.1 Tavapadon, an investigational D1/D5 dopamine receptor partial agonist, is being investigated as a once-daily treatment for the condition.
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TEMPO-1 (NCT04201093) was a phase 3, double-blind, randomized, placebo-controlled, parallel group, 27-week trial designed to assess the efficacy, safety, and tolerability of 2 fixed doses of tavapadon as a monotherapy for early PD.
About TEMPO-1
Trial Name: Fixed-Dose Trial in Early Parkinson's Disease (PD) (TEMPO-1)
Clinicaltrials.gov Identifier: NCT04201093
Sponsor: Cerevel Therapeutics, LLC
Summary: The purpose of this study is to evaluate the clinical efficacy, safety and pharmacokinetics (PK) of 2 fixed doses of tavapadon and placebo in participants with early PD.
The primary endpoint was the change from baseline in the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) parts II and III combined score. Additional key outcomes included changes in the MDS-UPDRS part II score and the percentage of participants who reported “much improved” or “very much improved” on the Patient Global Impression of Change.
The MDS-UPDRS is a tool used to assess different aspects of PD, including the impact of motor and non-motor experiences on daily living and motor complications. Part II focuses on motor experiences of daily living, while part III assesses motor function through body distribution scores for motor examination. Both sections contain numerous sub-scores that measure the severity and burden of the disease across various patient populations.
The combined scores for each part range from 0 to 184, with higher scores indicating greater severity. A decrease in score from baseline indicates an improvement in motor function.
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In total, 529 adults aged 40 to 80 with PD and a disease duration of less than 3 years were randomized to receive either a once-daily 5 mg or 15 mg dose of tavapadon. Ultimately, both treatment groups experienced significant improvements compared to placebo after 26 weeks (P < .0001). In the 5 mg dose group, changes in MDS-UPDRS scores decreased by an average of 9.7 points, and in the 15 mg dose group, they decreased by 10.2 points. The placebo group experienced a slight increase in score of 1.8.
Investigators also found that side effects observed in the TEMPO-1 trial were consistent with prior clinical trials, and that most of the reported adverse events were mild to moderate in severity.
The TEMPO clinical development program is evaluating the efficacy, safety and tolerability of tavapadon across a broad PD population. The program includes two phase 3 trials (TEMPO-1 and TEMPO-2) studying the drug's use as a monotherapy, as well as one phase 3 trial (TEMPO-3) examining its use in combination with other medications. AbbVie also plans to conduct a fourth, open-label extension trial (TEMPO-4) to assess the long-term safety and tolerability of tavapadon.
Cerevel Therapeutics, recently acquired by AbbVie, previously announced positive topline results from the phase three TEMPO-3 trial (NCT04542499), which evaluated the efficacy, safety and tolerability of tavapadon as an adjunctive therapy to levodopa in adults with PD.2
The trial successfully met its primary endpoint, demonstrating that patients taking tavapadon adjunctive to levodopa experienced a significantly longer duration of time with reduced motor symptoms and without troublesome dyskinesia compared to those taking levodopa with a placebo. The average increase in “on” time without dyskinesia was 1.7 hours for the tavapadon group compared to 0.6 hours for the placebo group (P < .0001).
“The TEMPO-1 data, coupled with the previously reported TEMPO-3 adjunctive trial findings, further support the potential of tavapadon for people living with Parkinson’s disease,” said Primal Kaur, MD, MBA, senior vice president of immunology, neuroscience, eye care and specialty development, at AbbVie, in the release.1 “This marks a significant step forward in our commitment to enhancing our neuroscience portfolio…and further demonstrates our dedication to supporting patients at all stages of this challenging neurological condition. We look forward to sharing additional data later this year from the TEMPO-2 monotherapy trial.”
The complete results from the TEMPO-1 study will be submitted for presentation at upcoming medical conferences and used to support regulatory submissions of tavapadon as a treatment for PD. The topline results from TEMPO-2 (NCT04223193), the phase 3 flexible-dose monotherapy trial for tavapadon, are anticipated by the end of 2024.
PD is the fastest growing global neurogenerative disorder.1 Given the pace at which the condition is increasing, as well as the fact that standard therapies are not available or affordable everywhere,3 a significant need exists to broaden the treatment landscape. According to Hubert H. Fernandez, MD, global principal investigator on TEMPO-3, professor of neurology and director at the Center for Neurological Restoration at Cleveland Clinic, current study results “demonstrate that tavapadon has the potential to offer an important new option for individuals living with this chronic, debilitating disease.”2
READ MORE: Neurology Resource Center
