The limitations of orally delivered levodopa have inspired a range of novel formulations designed to provide more constant levels of the drug. SynAgile has put its own spin on the molecule with a drug delivery dental retainer—and has secured debt financing to take it through phase 2.
Levodopa is the cornerstone of Parkinson’s disease treatment, but its effectiveness wanes as patients progress, with variations in plasma levels of the drug leading to motor symptoms. The emergence of motor symptoms is linked to factors including the limited oral bioavailability of levodopa, leading to the creation of formulations and devices with the potential to overcome the shortcomings.
SynAgile’s solution is a reusable custom dental retainer that is attached to a single-use container prefilled with a paste of levodopa and carbidopa. The paste of the two drugs, which are often given together in other products, is delivered to the back of the mouth and swallowed with saliva.
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If SynAgile is right, the device will continuously release the drugs at a slow rate for gastrointestinal absorption, thereby preventing the variations in plasma levels associated with existing options. The more consistent plasma concentrations could improve the management of motor symptoms.
SynAgile began a phase 2 clinical trial of the device, OraFuse, earlier this year. With enrollment in the 24-subject study underway, SynAgile has closed a $9 million convertible debt investment to fund it to completion. SynAgile will also use the money to start manufacturing preparations for phase 3.
The company disclosed the funding alongside news of the appointment of Warren Olanow, M.D., as chief medical officer. Olanow is CEO of Clintrex, a clinical research organization collaborating with SynAgile on the midphase study.