Tavapadon, a drug being tested to treat early Parkinson’s disease, has shown great promise in a Phase III trial by AbbVie, the pharmaceutical company announced this week.
Parkinson’s disease, which is lifelong, progressive, and has no cure, occurs when brain cells that make dopamine, a chemical that coordinates movement, stop working or die, according to the Michael J. Fox Foundation for Parkinson’s Research. This causes tremors, slowness, stiffness, and walking and balance problems, among other issues, for the 1 million people affected by the disease in the U.S. and 6 million affected worldwide.
Tavapadon aims to treat Parkinson’s motor symptoms by mimicking dopamine in a once-a-day oral dose. And the pivotal, late-stage study showed that the drug significantly improved the ability of patients to manage daily tasks such as walking and eating.
The positive results, said Dr. Primal Kaur, senior vice president of immunology, neuroscience, eye care, and specialty development at AbbVie, in a press release, “underscore the potential of tavapadon as a first-in-class D1/D5 partial agonist [medication targeting specific dopamine receptors] 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.”
A total of 304 adults between the ages of 40 and 80 were enrolled in the trial and were randomized to receive tavapadon 5 mg to 15 mg or placebo.
AbbVie acquired the drug through its $8.7 billion purchase of Cerevel Therapeutics last year. In other late-stage trials, tavapadon showed improvement of symptom control both as an add-on therapy to levodopa, the standard of care for Parkinson’s, and in fixed doses, as opposed to a range of doses.
The majority of side effects reported were consistent with prior clinical trials—including nausea, dyskinesia, dizziness, and headache—and were mild to moderate in severity.
“Parkinson’s disease imposes a profound burden on individuals living with this challenging neurological condition, significantly affecting their quality of life and management of daily activities. Right now, there is still an unmet need for treatments that deliver efficacy while minimizing unwanted side effects,” said Hubert H. Fernandez, MD, global principal investigator and the James and Constance Brown endowed chair in movement disorders, professor of neurology and director at the Center for Neurological Restoration at Cleveland Clinic, in AbbVie’s press release. These latest results, he said, “add to the growing evidence which suggests that tavapadon has the potential to offer an important new option for individuals living with Parkinson’s disease.”
AbbVie is on track to submit the New Drug Application to the U.S. Food & Drug Administration in 2025.
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