Cerevance, a private, Boston-based biotechnology company, said Wednesday that its most advanced experimental drug succeeded in a late-stage clinical trial focused on Parkinson’s disease.
Cerevance’s drug isn’t like most existing Parkinson’s therapies, which attempt to lift or protect levels of a molecule — dopamine — responsible for muscles moving smoothly. Instead, it inhibits a protein that, among other duties, regulates body coordination and motor function. By not targeting dopamine, Cerevance hopes to help Parkinson’s patients move better while avoiding the “dyskinesia,” or involuntary jerking motions, often caused by standard medications like levodopa.
Cerevance’s trial has been testing a couple once-daily doses of this drug, called solengepras, as an add-on treatment for patients who kept experiencing motor fluctuations even after taking levodopa and other drugs. The experiment randomized 341 participants to receive either a placebo, a lower dose of solengepras or a higher dose.
At the onset of the study, participants reported an average of 5.65 hours of daily “off” time, referring to periods when the effects of their medications waned and their symptoms came back or got worse. According to Cerevance, the higher dose of its drug met the trial’s main goal by significantly reducing these off periods. Specifically, average daily off time dropped by 0.61 hours compared to the placebo arm 12 weeks into treatment.
“On” time — the trial’s “key secondary” measure — also improved at the higher dose, though barely enough to hit statistical significance. When compared to the placebo group, patients in that arm had a 0.60-hour increase in on time without experiencing the kind of “troublesome” dyskinesia that can disrupt daily activities.
Cerevance said there were some positive findings on other surveys and scales that evaluate motor function, daily living and sleepiness. As for safety, the company said solengepras was generally well tolerated, with most adverse events being mild or moderate. The most frequently reported in the higher dose arm were headache, urinary tract infection, insomnia and nausea. There were also no serious adverse events reported in that arm.
Off time “has long been the main way we assess add-on therapies, but it captures only one aspect of the disease,” Robert Hauser, a trial investigator and director of the Parkinson’s Disease and Movement Disorder Center at the University of South Florida, said in a statement from Cerevance. “Looking at these measures together may give a fuller picture of a treatment's potential benefits for patients.”
Also in that statement, Craig Thompson, Cerevance’s CEO, said his company plans to discuss these latest results with the Food and Drug Administration to “determine next steps” for solengepras.
Cerevance formed in late 2016 as a joint venture between Lightstone Ventures and Takeda Pharmaceutical, which provided the research team, laboratory space and initial slate of drugs to test. The startup came equipped with $36 million, including $21.5 million from a Series A financing investment from Takeda and Lightstone.
Cerevance has stayed private since launching. In 2022, it caught the attention of Merck & Co. — which, through a heavily backloaded deal, agreed to team up to find new protein targets in the brain.
