Cerevel Reports Phase 3 Parkinson’s Success

Within the context of AbbVie’s $8.7 billion acquisition of Cerevel Therapeutics is now enjoying its turn in the limelight. Avapadon was brought to the forefront by Cerevel, when the company announced the successful completion of a phase 3 Parkinson’s disease study. This news also provided a slight lift to AbbVie as the company tries to conclude an agreement centered on another asset.

Emraclidine, Cerevel’s midphase schizophrenia drug, was the focal point of attention when AbbVie announced the plan to acquire the biotech company around the end of the previous year. However, tavapadon provides the first opportunity to begin making a return on the investment. Tavapadon is a dopamine D1/D5 receptor partial agonist which is taken orally once daily. Its purpose is to strike an equilibrium between considerable motor control activity and a desirable tolerability profile.

Cerevel presented the most compelling data in support of the hypothesis that the molecule achieves that equilibrium. In a phase 3 study, which included 507 individuals with Parkinson’s disease having motor fluctuations, the results were collected using randomization. The participants were required to have been taking a consistent dosage of levodopa for a minimum of four weeks before to the screening, and they were to continue taking the medication in conjunction with tavapadon or a placebo after the experiment began.

During the course of the 27-week experiment, patients who were given tavapadon had a much longer period of time without experiencing the distressing uncontrolled and involuntary movements referred to as dyskinesia within the medical field. According to the findings of the research, which gathered information on the state of motor function via the use of a self-completed house diary, individuals who were taking the medication suffered from problematic dyskinesia for 1.7 hours as opposed to 0.6 hours for the control group.

Although Cerevel has not yet disclosed data on this secondary objective, the firm has said that patients had a significant decrease in the duration of their symptoms. Also, the biotech is waiting until medical gatherings to provide a more in-depth analysis of the safety data, although they did say the molecule was well-tolerated overall with no unexpected reactions and most side effects being mild to moderate.

Volapadon regulatory filings and topline data from two phase 3 trials evaluating the drug as a monotherapy are on the agenda for the next meetings. In the second half of the year, when AbbVie plans to finalize the purchase, Cerevel will likely provide findings from the remaining phase 3 studies.

While announcing the acquisition of Cerevel, AbbVie’s chief commercial officer, Jeffrey Stewart, spoke with investors about tavapadon. Despite producing ABBV-951 and having a presence in severe Parkinson’s disease with Duopa, AbbVie is not present in the early, oral segment that tavapadon is targeting.

“Tavapadon … could be a nice complementary product up in the more early phases of the condition, so distinct from where we play now, but also complementary in terms of our commercial infrastructure. We believe it’s relatively modest—the bulk of the value does sit on emraclidine—but nonetheless a nice fit to where we can slot that in with our global teams across the world,” Stewart remarked.