SynAgile Corporation Announces Positive Phase 2 Top Line Results for DopaFuse® Levodopa-Carbidopa Delivery System

Singapore, SINGAPORE

SAN JOSE, Calif., Nov. 04, 2022 (GLOBE NEWSWIRE) -- SynAgile Corporation ( today announced positive results from its Phase 2 clinical trial of continuous levodopa-carbidopa (LD-CD) administration using SynAgile’s proprietary DopaFuse® delivery system. DopaFuse is a continuous, noninvasive oral LD-CD delivery system that does not require a surgical procedure or the use of a cumbersome infusion pump.

The study was a multi-center, open-label, 14-day clinical trial of 16 Parkinson’s disease patients in which treatment with standard intermittent oral LD-CD tablets was compared to LD-CD delivered via the DopaFuse system.

All primary endpoints were met. Plasma LD variability was significantly reduced with DopaFuse compared to standard LD-CD as assessed by both the fluctuation index (primary endpoint) and the coefficient of variation (p<0.001 for both). There was significant improvement with continuous LD-CD delivered by the DopaFuse system for both On time without severe dyskinesia and Off time (p<0.001 for both). Additionally, the UPDRS Part II score (a measure of activities of daily living) was significantly improved (p=0.016). There were no serious or clinically significant adverse events and oro-buccal reactions were mild and transient. Patients reported high satisfaction with the DopaFuse system.

“Motor complications can have a profoundly negative impact on the lives of Parkinson’s disease patients. A safe, convenient, noninvasive, continuous oral levodopa therapy would be a major advance in treatment,” said Prof. Warren Olanow, Professor Emeritus at the Mount Sinai School of Medicine in New York and CEO of Clintrex Research Corporation. “These results suggest that the DopaFuse LD-CD delivery system can provide a safe, noninvasive treatment for motor complications without the need for a surgical procedure,” said Prof. Olanow.

Ephraim Heller, CEO of SynAgile, noted that “SynAgile is now scaling up manufacturing at its facility in San Jose, CA in preparation for a double-blind Phase 3 clinical trial of the DopaFuse system.”

About OraFuse® and DopaFuse®

SynAgile is a privately-held startup company developing the OraFuse drug delivery platform for the administration of drugs where continuous oral delivery could be advantageous. OraFuse consists of a pre-filled, single-use, disposable drug container carried on a reusable tooth-attached retainer. The system continuously infuses medication into the mouth where it can be absorbed either through the gastrointestinal tract or via the buccal mucosa. SynAgile’s first product is DopaFuse, which uses the OraFuse technology to infuse a proprietary formulation of LD-CD into the mouth for the treatment of Parkinson’s disease. The LD-CD is swallowed with the patient’s saliva and absorbed via the gastrointestinal route. The DopaFuse drug formulation has no taste and the infusion is imperceptible to the patient. The DopaFuse system is designed so as to be imperceptible to others, comfortable to wear, and to not interfere with speech, swallowing, or drinking. DopaFuse is intended to enable patients with Parkinson’s disease to achieve more-constant plasma levodopa levels and thereby reduce their motor fluctuations.

OraFuse and DopaFuse are trademarks of SynAgile Corporation.

SynAgile Corporation
Ephraim Heller, (510) 908-3496