DopaFuse Delivery System
SynAgile's DopaFuse Delivery System
WILSON, Wyo., Oct. 27, 2021 (GLOBE NEWSWIRE) -- SynAgile is pleased to announce treatment of the first patient with the DopaFuse Delivery System in the SCOL (Study of Continuous Oral Levodopa) clinical trial. The patient was treated at the Luxembourg Institute of Health and the Centre Hospitalier de Luxembourg. The SCOL clinical trial is a Phase 2, open-label, multicenter study comparing the DopaFuse Delivery System to participants’ standard intermittent doses of oral levodopa for the treatment of Parkinson’s disease. 24 participants from approximately 6 sites in Spain, Luxembourg and Italy are expected to enroll in the study. The study is expected to complete in 2022.
According to Dr. C. Warren Olanow, CEO Clintrex Research Corporation and chief medical officer of SynAgile, “Continuous administration of levodopa has been shown to be the most effective medical therapy for reducing Off time in patients with Parkinson’s. DopaFuse presents an opportunity to noninvasively and continuously deliver levodopa. If proven effective, this product could significantly reduce the motor complications associated with Parkinson’s disease and avoid the need for surgical procedures.”
The DopaFuse Delivery System is a novel, 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 an investigational levodopa and 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.
SynAgile has developed OraFuse®, a proprietary drug delivery system that provides continuous drug delivery into the mouth. SynAgile was founded by highly successful serial inventor-entrepreneurs Adam Heller (CSO) and Ephraim Heller (CEO). The father-son team have over 300 patents and a track record which includes the founding of AngioScore and TheraSense. Adam Heller is also a coinventor of the first commercialized lithium thionyl chloride battery and a recipient of the US National Medal of Technology and Innovation.
More information can be found at https://clinicaltrials.gov/ct2/show/NCT04778176?recrs=b&cond=Parkinson&draw=2
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/16ea9686-68e9-4277-9323-cd4164190528