The Takeda spinout showed that a high dose of solengepras can shorten the periods during which difficult Parkinson’s disease symptoms like involuntary movements and sleepiness.
Takeda neuroscience spinout Cerevance will head to the FDA to discuss an approval path for the Parkinson’s disease therapy solengepras after the drug reduced the period of time in which standard drugs wear off and symptoms return during a late-stage clinical trial.
A high 150-mg dose of solengepras improved average daily “off time” by 0.61 hours as compared to placebo at week 12, meeting the main goal of the Phase 3 ARISE trial. This benefit showed up as early as the second week. Conversely, the therapy also increased “on time” without difficult symptoms like dyskinesia—the hallmark involuntary, erratic movements associated with Parkinson’s. This was a key secondary endpoint of the trial.
Cerevance also noted improvements in daytime sleepiness and quality of life, which “point to broad motor and non-motor benefit,” according to a Wednesday press release. The data were presented at the 2026 International Congress of Parkinson’s Disease and Movement Disorders in Seoul, Korea.
The ARISE study examined two solengepras doses as an adjunct treatment in 341 patients with Parkinson’s who experience motor fluctuations with standard-of-care levodopa and other medications. At baseline, patients on average experienced 5.65 hours of off time daily. That number dropped by 1.56 hours in patients receiving the 150-mg dose, versus a 0.95-hour drop in the placebo group. Participants in the higher-dose group also showed statistically significant motor improvements, additional secondary endpoints of the trial. Cerevance did not report efficacy data for the lower 75-mg dose.
The privately held company will now head to the FDA to discuss a regulatory path for solengepras.
As for safety, Cerevance said that solengepras was generally well tolerated. No serious adverse events were reported in the solengepras 150-mg dose group, compared with a rate of 1.8% for the 75-mg arm and 0.9% for placebo, and overall discontinuation rate due to adverse events across all arms of the trial, including placebo, was 3.5%. The most commonly reported safety events were headache and urinary tract infection.
Solengepras targets the GPR6 receptor to improve motor and non-motor function without altering dopamine levels or signaling as do standard Parkinson’s therapies, which do not address the underlying cause of the disease and often wear off as the brain’s ability to store dopamine continues to fade. Levodopa specifically can cause dyskinesia over time, leading to increases in off time. Cerevance reported dyskinesia in 4.4% of patients receiving the high dose of solengepras compared to 1.8% for placebo.
Cerevance is one of a few companies working to improve treatment options for patients with Parkinson’s. Late last month, AbbVie received approval for tavapadon, which is to be marketed as Juvmo. The drug, which is the first selective D1/D5 receptor agonist to become available in the U.S., came from the $8.7 billion takeout of Cerevel in December 2023.
But drug development in the space has been tough, with many failed attempts such as Biogen and Denali’s BIIB122. The therapy failed to slow disease progression during a Phase 2b trial and was discontinued earlier this year.
Other biotechs in the game include Ionis Pharmaceuticals, Eli Lilly’s Ventyx Therapeutics and Insilico Medicine.
