Phase 2 Trial Tests DopaFuse for Continuous Oral Levodopa Delivery

16 Parkinson's patients move from daily tablets to system's retainer for trial

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by Patricia Inácio, PhD |

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SynAgile announced the completion of a Phase 2 clinical trial evaluating DopaFuse, its noninvasive system for the continuous oral delivery of levodopa/carbidopa to people with Parkinson’s disease.

Sixteen adults being treated with levodopa/carbidopa (LD/CD) in a tablet form were enrolled in the open-label study into the safety and tolerability of DopaFuse, and its effectiveness in easing or preventing the fluctuations known to accompany long-term use of this standard Parkinson’s therapy, the company stated in a press release.

Top-line trial data is expected in late September and the company plans to publish findings in a scientific journal and present them at an upcoming conference, Ephraim Heller, CEO of SynAgile, said in an email reply to Parkinson’s News Today.

The company is also planning a pivotal Phase 3 trial of the DopaFuse system in Parkinson’s patients.

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DopaFuse consists of a reusable custom-made dental retainer, its case, and a pre-filled, single-use container that slowly and continuously releases LD/CD in paste form into the back of the mouth, where it mixes with saliva. The company reports that it is easy to remove and store for eating, dental cleanings, and like activities.

Continuous, slow delivery of oral levodopa aims to ease ‘off’ periods

Parkinson’s is caused by the loss of neurons, or nerve cells, that produce the neurotransmitter dopamine — a chemical messenger essential for muscle control.

Levodopa, a mainstay Parkinson’s treatment, works to increase brain levels of dopamine by delivering its precursor to cells. It typically is used in combination with carbidopa, an agent that helps prevent levodopa’s breakdown.

Over time, however, patients often experience “off” periods, times in which the treatment’s effects wear off and symptoms return before another dose can be taken.

“Continuous administration of levodopa has been shown to be the most effective medical therapy for reducing Off time in patients with Parkinson’s,” Warren Olanow, chief medical officer of SynAgile, said in an October 2021 press release marking DopaFuse’s use in a first trial patient. “If proven effective, this product could significantly reduce the motor complications associated with Parkinson’s disease and avoid the need for surgical procedures.”

According to the company’s website, LD/CD delivered with the DopaFuse device is swallowed with saliva and absorbed in the gastrointestinal tract. The system’s continuous and slow rate of treatment delivery is expected to sustain more stable levodopa/carbidopa levels and increase “on” time periods, when levodopa is working well and disease motor symptoms such as dyskinesia (involuntary movements) are controlled.

The Phase 2 trial (NCT04778176) — called SCOL (Study of Continuous Oral Levodopa) — enrolled patients, ages 30 and older,  across five sites in  Spain, Luxembourg, and Italy. All reported having at least two hours of “wearing off time” each day, and were on stable daily LD/CD doses, ranging from 400 to 1,200 mg total, for at least 28 days before entering the trial.

Patients wore the container for about five hours daily, with an hourly LD/CD dosing of 50mg/13mg or 68mg/17mg at a flow rate matched to their standard dose of the treatment in a tablet form.

A main goal is to evaluate whether the DopaFuse System eases fluctuations in blood levels of levodopa and off times compared to the standard doses by comparing changes from the trial’s first day to day 15.

Additional goals include assessing the system’s safety and tolerability, its effectiveness at relieving motor symptoms, and its pharmacokinetics profile, or the movement of a medicine into, through, and out of the body.

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