Treatment with tavapadon as a fixed-dose single therapy significantly improved motor function in early stage Parkinson’s disease, according to top-line data from a completed Phase 3 trial.
Full results from TEMPO-1 (NCT04201093) will be presented at future medical meetings and support regulatory submissions toward the investigational therapy’s approval. Tavapadon is being developed by Cerevel Therapeutics, now part of Abbvie, which announced the results in a press release.
Tavapadon is also being tested as a single therapy given in flexible doses to early-stage Parkinson’s patients in the Phase 3 TEMPO-2 (NCT04223193) trial and as an add-on to levodopa in patients with motor fluctuations in the Phase 3 TEMPO-3 (NCT04542499) study. Data from TEMPO-2 is expected later this year.
“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, Abbvie’s senior vice president of immunology, neuroscience, eye care, and specialty development.
In Parkinson’s the progressive loss of dopaminergic neurons trigger the onset of symptoms such as tremors, rigidity, slowness of movement, and gait and balance issues. Dopaminergic neurons are nerve cells that produce dopamine, a chemical messenger important for motor control.
Results with tavapadon
Tavapadon is a dopamine agonist that binds to dopamine D1 and D5 receptors on the surface of neurons to mimic the action of dopamine, which should help ease motor symptoms.
Data from TEMPO-3 showed the therapy increased on time, that is, when medication effectively controls motor symptoms, without troublesome dyskinesia, or sudden, involuntary movements that’s commonly associated with levodopa’s long-term use. Levodopa is the mainstay treatment for Parkinson’s.
TEMPO-1 evaluated the efficacy, safety, and tolerability of tavapadon as a single therapy for early Parkinson’s. The trial enrolled 529 adults, ages 40 to 80, who were randomly assigned to one of two doses (5 mg, 15 mg) of the therapy, or a placebo, for 27 weeks (about six months).
The study’s main goal was to assess changes in the severity of motor symptoms using the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts 2 and 3 combined score.
The results showed both doses of tavapadon significantly decreased this score over the placebo, corresponding to a decrease of 9.7 points with the 5 mg dose and 10.2 points with 15 mg. A decrease in MDS-UPDRS scores reflect improved motor function. The trial also met its secondary goal of a statistically significant and clinically meaningful improvement in motor aspects of experiences of daily living, as assessed by Part 2 of the MDS-UPDRS.
The therapy’s safety profile was consistent with previous trials, with most adverse events being mild to moderate in severity.
“Parkinson’s disease is the fastest growing neurodegenerative disorder in the world and there is a significant need for new treatment options. [T]hese findings underscore [tavapadon’s] potential as a new treatment for those living with Parkinson’s disease,” Kaur said in an email to Parkinson’s News Today. “This marks a significant step forward in our commitment to enhancing our neuroscience portfolio and supporting patients at all stages of this chronic and debilitating neurological condition. We look forward to sharing additional data from the Phase 3 flexible-dose monotherapy trial, TEMPO-2, later this year.”
Patients who complete TEMPO-1, TEMPO-2, and TEMPO-3 can enroll in TEMPO-4 (NCT04760769), a Phase 3 open-label extension trial testing tavapadon’s efficacy and safety over 58 weeks, or about 13 months, of treatment.
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