About DopaFuse

  • Designed for Parkinson's Disease patients
  • Provides continuous delivery of levodopa
  • May provide more stable drug levels in the blood, potentially reducing "Off" time
  • Uses the OraFuse platform

About OraFuse®

  • OraFuse is SynAgile's proprietary technology for continuous drug delivery in the mouth
  • Can be used for numerous drugs

OraFuse Technology:
A novel, non-invasive method of drug delivery in the mouth

Drug Types

Orally-delivered drugs, including:

Narrow therapeutic index drugs.
Drugs that cannot be formulated for extended release



Buccally-delivered drugs



Topical drugs for the mouth, pharynx, and esophagus

Benefits



More stable plasma drug concentrations. Fewer dose-related side effects.

Allows buccal delivery of drugs requiring frequent or continuous dosing, rather than just drugs requiring episodic dosing.

Allows topical delivery of drugs requiring frequent or continuous dosing to the mouth, pharynx and esophagus.

Phase 2 Clinical Trial

SynAgile is currently conducting a Phase 2 clinical trial on the DopaFuse Delivery System titled “Study of Continuous Oral Levodopa” (SCOL) in order to study the safety and efficacy of DopaFuse. The SCOL study is enrolling 24 patients in Italy, Luxembourg and Spain beginning in June of 2021.

Founders

SynAgile was founded by highly successful serial inventor-entrepreneurs Adam Heller (CSO) and Ephraim Heller (CEO). The father-son team have over 300 patents (most in use) and a track record which includes the founding of AngioScore (sold for $235 million) and TheraSense (which went public and was later sold for $1.2 billion). 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, the highest technology honor in the United States.

The SynAgile founding team began developing OraFuse after seeing an opportunity to improve patients’ quality of life via a new class of drug delivery devices.

News

Trial Regulatory Approval in Luxembourg

January 25th, 2021

SynAgile has received approval to begin the SCOL Phase 2 clinical trial in Luxembourg. Professor Rejko Kruger will act as the Luxembourg Institute of Health’s Principal Investigator. Rejko Krueger, MD, is a Professor of Clinical and Experimental Neuroscience, head of the Department for Translational Medicine at the Luxembourg Centre for Systems Biomedicine (LCSB) of the University of Luxembourg and a movement disorders specialist at Centre Hospitalier de Luxembourg (CHL). The study is expected to begin in June 2021.

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Trial Regulatory Approval in Italy

January 25th, 2021

SynAgile has received approval to begin the SCOL Phase 2 clinical trial in Italy. Professor Fabrizio Stocchi, MD, PhD will serve as the Principal Investigator of the study. Prof. Stocchi is the Professor of Neurology, Consultant in Neurology and Director of the Parkinson's Disease and Movement Disorders Research Centre at the Institute for Research and Medical Care IRCCS San Raffaele Rome and University “La Sapienza” Rome. The study will be conducted at two sites in Rome (IRCCS San Rafaele Pisana and Policlinico Tor Vergata) as well as San Raffaele Cassino.

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Federal law limits the use of DopaFuse to Investigational Use Only. DopaFuse is not available for sale.