New daily pill improves Parkinson's symptoms in phase 3 trial

Clinical-stage biopharmaceutical company Cerevance has announced the first results from ARISE, a phase 3 clinical trial of a new drug called solengepras.

The once-daily oral drug was tested as an add-on therapy for people with Parkinson's for whom standard medications (like levodopa) were no longer managing symptoms effectively.

The 12-week trial included 341 people with Parkinson's, with participants receiving daily solengepras (75 mg or 150 mg) or placebo.

What were the results?

After 12 weeks, people taking 150 mg of solengepras had more 'ON' time (when their symptoms were well controlled) compared to those on placebo. Importantly this increase in 'ON' time did not come with troublesome dyskinesia, or uncontrolled movement, which is associated with larger doses of current Parkinson's medications.

In addition to this, participants taking 150 mg of solengepras showed improvements in measures of daily living and quality of life.

Finally, solengepras was well-tolerated by participants, with mostly mild to moderate side effects and no serious side effects occurred in the 150 mg group.

A new type of drug for Parkinson's?

Unlike traditional Parkinson's drugs, solengepras aims to improve movement without altering dopamine levels.

Instead this new drug is designed to treat Parkinson's by restoring the balance between the two pathways controlling movement in the brain, effectively turning off the brain's movement "brakes" and improving mobility.

Solengepras represents a new way to treat Parkinson's, which scientists hope will work alongside existing medications to improve symptoms with fewer side effects. These trial results suggest that this approach is working.

What happens next?

These positive results mean solengepras can now be assessed by regulatory authorities who decide whether drugs are safe and effective enough to be made available to patients.

In their announcement about the results Cerevance indicated they were intending to start discussions with the US regulator, the Food & Drug Administration (FDA), to plan next steps for pursuing these approvals.

Claire Bale, Associate Director of Research at Parkinson's UK, comments: "These phase 3 results indicate that solengepras could be an important new treatment option for Parkinson's.

"The most exciting thing about this new drug is that it works in a different way to existing Parkinson's medications to improve symptoms. As shown in this recent trial, this means it can be used alongside existing drugs to offer greater symptom control without increasing troublesome side effects to improve quality of life.

"We are keen to see this important new treatment made available to people with Parkinson's in the UK as soon as possible and will be reaching out to the company behind solengepras to offer our support."