On Thursday, AbbVie Inc ABBV launched topline outcomes from its pivotal Section 3 TEMPO-1 trial for tavapadon as a monotherapy in early Parkinson’s illness.
Tavapadon is an investigational D1/D5 dopamine receptor partial agonist being studied as a once-daily therapy for Parkinson’s illness. AbbVie added the drug candidate with its $8.7 billion buyout of Cerevel Therapeutics.
The TEMPO-1 trial evaluated the efficacy, security and tolerability of two mounted doses (5 mg and 15 mg, as soon as day by day) of tavapadon as a monotherapy in adults with early Parkinson’s illness.
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The trial met its major endpoint – sufferers handled with tavapadon in each dose teams skilled a statistically important discount (enchancment) from baseline in comparison with placebo (placebo: +1.8; 5 mg: -9.7; 15 mg: -10.2 versus placebo) within the Motion Dysfunction Society – Unified Parkinson’s Illness Score Scale (MDS-UPDRS) Elements II and III mixed rating at week 26.
MDS-UPDRS assesses motor and non-motor signs of Parkinson’s illness.
The TEMPO-1 trial additionally met the important thing secondary endpoint, demonstrating a statistically important and clinically significant enchancment in motor points of experiences of day by day dwelling (MDS-UPDRS Half II) in each tavapadon dose teams in comparison with placebo at week 26.
The security profile noticed within the TEMPO-1 trial was in step with prior scientific trials. Nearly all of antagonistic occasions reported have been delicate to reasonable in severity.
Full outcomes from the TEMPO-1 research will probably 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 TEMPO-2, the Section 3 flexible-dose monotherapy trial for tavapadon, are anticipated by the tip of 2024.
Value Motion: ABBV inventory is up 0.33% at $191.90 on the final verify on Wednesday.
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