AbbVie has completed a hat trick of phase 3 wins for its Parkinson’s disease prospect tavapadon, teeing the drugmaker up to file for FDA approval in 2025.
The Big Pharma acquired the once-daily oral dopamine D1/D5 receptor partial agonist in its $8.7 billion takeover of Cerevel Therapeutics. AbbVie primarily bought Cerevel to snag the schizophrenia prospect emraclidine. But with that drug candidate flunking a pair of phase 2 trials, tavapadon offers the company a shot at emerging from the floundering buyout with a driver of sales growth.
Tavapadon hit the primary endpoint in one phase 3 trial in April, before AbbVie closed the takeover, and racked up another victory in September. AbbVie completed the set Monday by reporting data from a trial that compared a flexible dose of the molecule to placebo in adults with early Parkinson’s.
After 26 weeks, patients on tavapadon improved by 10.3 points on a measure of motor function, versus a 1.2-point improvement on placebo. The difference between the arms caused the trial to hit its primary endpoint. AbbVie also reported a statistically significant improvement on motor aspects of experiences of daily living, one of the two measures combined in the primary endpoint.
The safety profile was consistent with earlier studies, AbbVie said, with most adverse events being mild or moderate in severity. Safety is a key focus for AbbVie, which has identified the lack of sedation seen with other dopamine agonists as a point of difference. The company views the rate of impulse control disorders, a well-known adverse effect of dopamine agonists, as another area in which it may have an edge.
Long-term safety data, which could be published early next year, may give a clearer picture of how the drug candidate is shaping up, but AbbVie has already committed to seeking FDA approval on the basis of the studies. Speaking at a Citi event last week, AbbVie Chief Scientific Officer Roopal Thakkar, M.D., said the results of the first two tavapadon studies “exceeded our initial thinking.”