New once-daily Parkinson's pill cuts "off" time in phase 3 trial of 341 patients
Cerevance's experimental drug solengepras reduced the daily time people with Parkinson's spend with poorly controlled symptoms in a 341-person phase 3 trial, without adding troublesome involuntary movements.
An experimental once-daily pill called solengepras reduced the time people with Parkinson's spend with poorly controlled symptoms in a phase 3 trial of 341 patients, the drug's developer Cerevance announced on 7 October. The results were presented at an international Parkinson's congress in Seoul.
The drug works without changing dopamine
Most Parkinson's medicines, including levodopa, work by boosting or mimicking dopamine. Over time they can lose effect between doses, leaving "off" periods when symptoms return, and higher doses can cause dyskinesia, or involuntary movements.
Solengepras takes a different route. It blocks a receptor called GPR6 in the brain's indirect movement pathway, aiming to rebalance the circuits that control movement, which Parkinson's UK described as effectively releasing the brain's movement "brakes".
About 37 minutes less "off" time a day
In the ARISE trial, people already on standard treatment who still had at least three hours of "off" time a day took 75 mg or 150 mg of solengepras, or a placebo, for 12 weeks. At the higher dose, daily "off" time fell by 0.61 hours more than with placebo, and the benefit appeared from the second week.
"On" time without troublesome involuntary movements rose by 0.6 hours versus placebo, and patients also reported better daily functioning, less daytime sleepiness and improved quality of life. No serious side effects were seen at 150 mg; the most common were headache and urinary tract infection.
“These phase 3 results indicate that solengepras could be an important new treatment option for Parkinson's.” — Claire Bale, Associate Director of Research, Parkinson's UK
Regulators will now decide
The results come from the company's announcement and have not yet been published in a peer-reviewed journal. Cerevance plans to discuss next steps with the US Food and Drug Administration, and the positive results mean the drug can now be assessed by regulators, Parkinson's UK said. Any approval would be as an add-on to existing treatment.
Research into other parts of the disease continues too, such as a study of brain cells that show resilience in Parkinson's.
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