TW001: Oral formulation of edaravone.
Edaravone is a free radical scavenger that targets oxidative stress, a process known to play an important role in the pathogenesis of ALS. In 2015, the intravenous formulation of edaravone, known as Radicut®, was approved in Japan for the indication ALS and in the USA it was approved under the name Radicava® in May 2017. Radicut® and Radicava® are administered intravenously and the dosing regimen consists of 10 days of treatment, over a period of two weeks, followed by a 16-day drug holiday, a period in which the patient is not given edaravone.
In 2015, Treeway demonstrated in clinical trials that adequate levels of edaravone can be obtained in the blood by oral administration of edaravone. At Treeway, orally administered edaravone is referred to as TW001. Subsequently, a development plan was made to bring TW001 to the market. Currently, this plan is being executed. The approval of Radicava® does not interfere with Treeway’s plans for TW001.
Treeway is developing Edaravone as a formulation so patients can take it via the mouth (oral) each day as a sustained delivery medicine. TW001 is currently in clinical stage. TW001 was awarded Orphan Drug Designation status by the European Medicines Agency in 2014 and by the Food and Drug Administration in 2015.
We are determined to make TW001 available to the patients as quickly as possible so ALS patients all over the world can take this drug and thereby delay the disease process.
Patients interested in participating in a clinical study with TW001 can find more information at www.tricals.org