SynAgile

About SynAgile

SynAgile is a privately-held pharmaceutical company founded by Ephraim Heller in 2011, focused on addressing the challenges of treating Parkinson's disease. The company is developing the OraFuse™ drug delivery platform, a non-invasive technology for the continuous oral administration of medications.

The company's lead product is the DopaFuse™ system, which is designed to manage motor fluctuations in Parkinson's patients. This condition often arises from the variable plasma levels associated with standard intermittent oral doses of Levodopa-Carbidopa (LD-CD), the primary treatment for the disease. The DopaFuse system aims to provide more stable plasma concentrations of LD-CD, thereby reducing debilitating 'off' periods and improving symptom control.

The DopaFuse system consists of a reusable, custom-fit dental retainer that holds a pre-filled, single-use, disposable drug container. This container continuously releases a proprietary, taste-free LD-CD paste into the back of the mouth, which is then swallowed with saliva and absorbed through the gastrointestinal tract. The device is designed to be discreet, comfortable, and not interfere with daily activities like speaking or drinking. The system offers a non-surgical alternative to more invasive treatments.

SynAgile's business model centers on the development and eventual commercialization of its proprietary drug delivery technologies. The company secures funding to advance its products through clinical trials. It has successfully completed Phase 2 clinical trials which demonstrated a significant reduction in plasma LD variability and motor complications compared to standard oral tablets. Following positive Phase 2 results announced in late 2022, the company is scaling up manufacturing in preparation for a Phase 3 clinical trial. SynAgile has raised capital through various funding rounds, including a $9 million convertible debt investment in 2021 and a $10.4 million Series B round in 2017, with investors including TAMCAP and The Michael J. Fox Foundation.