On Thursday, Cerevel Therapeutics Holdings Inc. CERE launched topline outcomes from its pivotal Part 3 TEMPO-3 trial for tavapadon in Parkinson’s illness.
The TEMPO-3 trial evaluated the efficacy, security, and tolerability of tavapadon as an adjunctive remedy to levodopa (LD) in adults.
The trial met its major endpoint – sufferers handled with tavapadon adjunctive to LD skilled a clinically significant and statistically important improve of 1.1 hours in whole “on” time with out troublesome dyskinesia in comparison with these handled with LD and placebo (1.7 hours vs. 0.6 hours, p <0.0001).
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A statistically important discount in “off” time, the important thing secondary endpoint, was additionally noticed for the tavapadon therapy arm.
“Tavapadon’s novel mechanism of motion, which selectively prompts the D1/D5 dopamine receptors, has demonstrated the potential to offer folks residing with Parkinson’s illness the correct stability of motor management, security, and tolerability,” mentioned Raymond Sanchez, M.D., chief medical officer, Cerevel Therapeutics.
Tavapadon was usually nicely tolerated. The security profile noticed within the TEMPO-3 trial was according to prior scientific trials of tavapadon.
Nearly all of antagonistic occasions reported had been gentle to reasonable in severity.
Full outcomes from the TEMPO-3 examine can be submitted for presentation at future medical conferences and used to assist regulatory submissions of tavapadon as a therapy for Parkinson’s illness.
Topline outcomes from the Part 3 monotherapy trials for tavapadon, TEMPO-1, and TEMPO-2 are anticipated within the second half of 2024.
In December, AbbVie Inc. ABBV agreed to accumulate Cerevel Therapeutics for a complete fairness worth of roughly $8.7 billion, or $45 per share in money. The transaction is anticipated to shut in mid-2024.
Value Motion: CERE shares are up 1.08% at $42.05 on the final verify Thursday.
Photograph by Milad Fakurian on Unsplash
