Dutch biotechnology company Treeway has successfully completed two Phase I clinical trials of TW001 for ALS (see March 2015 news). TW001 is an oral formulation of edaravone, a free radical scavenger and antioxidant drug originally approved in Japan for treating stroke. Earlier this year, Mistubishi Tanabe Pharma obtained approval to market edaravone for ALS in Japan under the name Radicut (see June 2015 news), and the company presented results of their Phase III clinical trials in ALS at the International Symposium on ALS/MND in Orlando, Florida. Unlike edavarone, which requires intravenous administration, TW001 can be taken orally, allowing for more convenient and frequent drug administration. The Phase I trials included both single and dose escalation studies, and demonstrated that TW001 is safe and well-tolerated. Treeway is aiming to begin a pivotal phase II/III trial of TW001 in 2016.
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