AbbVie Parkinson’s disease therapy hits main goal in late-stage trial

AbbVie (NYSE:ABBV) announced Thursday its experimental therapy Tavapadon for Parkinson’s disease reached the primary endpoint in a Phase 3 trial, indicating a statistically significant improvement in disease severity as a single agent.

Based on topline data from its TEMPO-1 trial, the company said the once-daily treatment across two dose levels, 5 mg, and 15 mg, reduced a clinical measure called MDS-UPDRS Parts II and III combined score versus placebo to reach the main goal at week 26.

The study also met a key secondary endpoint based on MDS-UPDRS Part II with a statistically significant and clinically meaningful improvement at Week 26 compared to placebo.

AbbVie (ABBV) added that the safety profile of Tavapadon was found to be consistent with data from prior trials, and the majority of adverse events were mild to moderate in severity.

Its TEMPO clinical development program for Tavapadon in PD comprises two monotherapy Phase 3 trials, TEMPO-1 and TEMPO-2.

A Phase 3 flexible-dose monotherapy trial, TEMPO-2, is expected to generate topline data by the end of the year. Meanwhile, AbbVie (ABBV) expects to use full TEMPO-1 results for future regulatory submissions for Tavapadon in PD.