US-based pharmaceutical company AbbVie has reported that the Phase III TEMPO-2 trial of tavapadon, its D1/D5 partial agonist candidate for early-stage Parkinson’s disease, met its primary endpoint.
The double-blind, placebo-controlled trial was part of AbbVie’s comprehensive TEMPO clinical development programme and assessed tavapadon’s safety, efficacy and tolerability as a single agent.
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It enrolled 304 adult subjects aged between 40 and 80 years, who had all been diagnosed with Parkinson’s disease less than three years earlier.
Subjects given tavapadon in the trial experienced significant improvements in motor function compared with those given placebo.
The tavapadon cohort showed a statistically significant reduction from baseline in Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) combined score of Parts II and III during the 26-week period.
The trial also achieved a key secondary endpoint in indicating a meaningful improvement in daily living motor experiences as reflected in the MDS-UPDRS Part II scores.
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By GlobalDataTavapadon’s safety profile in the trial was consistent with previous studies, with most adverse events being mild to moderate.
Following these results, AbbVie aims to submit a new drug application (NDA) application to the US Food and Drug Administration (FDA) next year.
AbbVie immunology, neuroscience, eyecare and speciality development senior vice-president Primal Kaur said: “The positive results across all three Phase III TEMPO trials underscore the potential of tavapadon as a first-in-class D1/D5 partial agonist for the treatment of Parkinson’s disease.
“With these data in hand, we look forward to working with regulatory agencies to assess next steps, bringing us one step closer to providing tavapadon for those living with this chronic, debilitating disease.”
In September, AbbVie published results from the Phase III TEMPO-1 trial of tavapadon, in which the drug was found to significantly reduce the burden of Parkinson’s disease.
