On Thursday, Cerevel Therapeutics Holdings Inc. (NASDAQ:CERE) released topline results from its pivotal Phase 3 TEMPO-3 trial for tavapadon in Parkinson’s disease.
The TEMPO-3 trial evaluated the efficacy, safety, and tolerability of tavapadon as an adjunctive therapy to levodopa (LD) in adults.
The trial met its primary endpoint – patients treated with tavapadon adjunctive to LD experienced a clinically meaningful and statistically significant increase of 1.1 hours in total “on” time without troublesome dyskinesia compared to those treated with LD and placebo (1.7 hours vs. 0.6 hours, p <0.0001).
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A statistically significant reduction in “off” time, the key secondary endpoint, was also observed for the tavapadon treatment arm.
“Tavapadon’s novel mechanism of action, which selectively activates the D1/D5 dopamine receptors, has demonstrated the potential to provide people living with Parkinson’s disease the right balance of motor control, safety, and tolerability,” said Raymond Sanchez, M.D., chief medical officer, Cerevel Therapeutics.
Tavapadon was generally well tolerated. The safety profile observed in the TEMPO-3 trial was consistent with prior clinical trials of tavapadon.
The majority of adverse events reported were mild to moderate in severity.
Full results from the TEMPO-3 study will be submitted for presentation at future medical meetings and used to support regulatory submissions of tavapadon as a treatment for Parkinson’s disease.
Topline results from the Phase 3 monotherapy trials for tavapadon, TEMPO-1, and TEMPO-2 are expected in the second half of 2024.
In December, AbbVie Inc. (NYSE:ABBV) agreed to acquire Cerevel Therapeutics for a total equity value of approximately $8.7 billion, or $45 per share in cash. The transaction is anticipated to close in mid-2024.
Price Action: CERE shares are up 1.08% at $42.05 at the last check Thursday.
Photo by Milad Fakurian on Unsplash
