Date: 2015-12-10
Type of information: Initiation of preclinical development
phase:
Announcement:
Company: Treeway (The Netherlands)
Product: TW001 - edaravone
Action
mechanism: neuroprotective agent/free radical scavenger. TW001, Treeway’s lead compound, is an oral formulation of edaravone. Edaravone is a well-established free radical scavenger, which targets oxidative stress, a process that plays an important role in ALS. Intravenously administered edaravone has been shown to slow down disease progression in ALS patients in previous Japanese clinical trials. Currently, edaravone is marketed in Japan by Mitsubishi Tanabe as an intravenous formulation (Radicut®) for the indication stroke and ALS. The intravenous formulation of edaravone is administered to ALS patients via 1-hour infusions in a hospital setting.
Treeway has developed an oral formulation (TW001) to overcome the problems associated with intravenous administration. The reformulated drug allows for chronic daily use and its route of administration (oral) is patient friendly.
Disease: amyotrophic lateral sclerosis
Therapeutic area: Neurodegenerative diseases - Rare diseases
Country:
Trial details:
Latest
news: * On December 10, 2015, Treeway, a biotech company developing therapies against (ALS), announced the completion of two successful phase I trials with their lead compound TW001, a new more patient friendly oral formulation of the Japanese stroke and ALS therapy edaravone. Treeway, founded by two Dutch ALS patients, aims at speeding up ALS research in collaboration with academic and research centers around the globe. TW001 was tested in both single and multiple dose phase l studies in healthy volunteers and in ALS patients. In the two Phase 1 clinical studies TW001 was shown to be safe and well tolerated and adequate exposure levels with the oral formulation were detected. Based on these trial data, the company is now aiming to start a pivotal phase 2/3 study in 2016. Earlier, Treeway obtained orphan drug designation for edaravone of ALS from both the FDA and EMA.
