SynAgile Completes Enrollment of its Phase 2 Clinical Trial of its DopaFuse Delivery System


SAN JOSE, Calif., Sept. 01, 2022 (GLOBE NEWSWIRE) -- SynAgile Corporation (www.SynAgile.com) is pleased to announce it has completed enrollment of its clinical trial evaluating the DopaFuse Delivery System for the treatment of Parkinson’s Disease (“PD”). The clinical trial, called SCOL (Study of Continuous Oral Levodopa) is a Phase 2, open-label, multi-center study comparing the DopaFuse Delivery System to participants’ standard intermittent doses of oral levodopa. Sixteen participants with PD from five sites in Spain, Luxembourg, and Italy have completed the study.

More information on the clinical trial can be found at https://clinicaltrials.gov/ct2/show/NCT04778176

About DopaFuse
The DopaFuse Delivery System is a patented, intra-oral system that continuously and noninvasively delivers levodopa and carbidopa at a controlled rate for patients with PD. The DopaFuse System consists of an oral retainer, its case, and a prefilled, single-use drug container that continuously releases a levodopa-carbidopa paste in the back of the mouth.

About Parkinson’s Disease
Parkinson’s Disease is a progressive neurodegenerative disorder that affects predominately dopaminergic neurons, resulting in declining dopamine levels and ensuing symptoms such as tremor, rigidity, and difficulty with walking, balance and coordination. Levodopa-carbidopa is the first line of treatment, which can restore dopamine levels and reduce motor symptoms. Several classes of drugs have been developed to treat motor complications, but frequently they do not provide adequate benefit. Surgical therapies can be helpful in more advanced cases, but these procedures are highly invasive and associated with potentially serious and troublesome adverse effects.

About SynAgile
SynAgile is a pharmaceutical company focused on developing and commercializing therapeutics using its proprietary OraFuse® noninvasive, continuous, oral dosing technology, with an initial focus on treating debilitating motor complications in patients with Parkinson's disease using its DopaFuse™ levodopa-carbidopa delivery system. SynAgile is based in San Jose, California.

OraFuse and DopaFuse are registered trademarks of SynAgile Corporation.

For additional information, please contact:

Ephraim Heller, Chief Executive Officer
SynAgile Corporation
625 River Oaks Parkway
San Jose, CA 95134
(510) 788-4435
email: eheller@synagile.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9f8be7d9-7b5a-48a9-ade8-451176aca6d1


DopaFuse Delivery System