The chief medical officer of Cerevel Therapeutics detailed phase 2 data of its investigational agent tavapadon, which has been studied in patients with Parkinson disease.
"Our hope is that in the phase 3 program, we can enrich the population by having that threshold of 2 points or greater. We don’t see that floor effect in the phase 2 setting, but the data gave us great confidence that we could achieve even greater efficacy, as well as the placebo response peaks at week 18.”
Cerevel Therapeutics’ investigational agent tavapadon is in the midst of being assessed in a slew of phase 3 trials, dubbed the TEMPO program, that will study the effects of the drug in both early-onset and late-onset Parkinson disease (PD). Prior to the initiation of these trials, the drug demonstrated its capabilities across a number of end points in a phase 2 setting.
Most notably, the study met its primary end point, demonstrating a statistically significant improvement in baseline in motor symptoms as evaluated by the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part III score at 15 weeks in those treated with tavapadon as compared to placebo. The study included 57 patients, age 45 to 80 years, with early-stage PD, and used the Patient Global Impression of Change (PGI-C) and the Epworth Sleepiness Scale (ESS) as secondary end points.
Raymond Sanchez, MD, chief medical officer, Cerevel Therapeutics, sat down with NeurologyLive to discuss the most notable findings from the study, and how they compare to other previously observed treatments for PD.