Treeway has reported positive results from a Phase I clinical trial designed to analyse the bioavailability of TW001 in comparison with Radicavaâ for the treatment of amyotrophic lateral sclerosis (ALS).
Findings of the trial have showed increased bioavailability of TW001 in a single-dose treatment, with no safety concerns developed within the subject group.
Theresults have implied the potential of TW001 to improve treatment strategies for ALS patients.
During the randomised cross-over comparative bioavailability trial, a single oral dose of 140mg of TW001 was tested against a one-hour intravenous infusion of 60mg of Radicavaâin 18 healthy subjects.
Treeway chief development officer Ronald van der Geest said: “It is Treeway’s mission to identify novel treatment routes for ALS patients and we believe that this study indicates that an oral formulation of edavarone may offer patients a better quality-of-life through a simpler and more effective route of administration.
“Given the nature of this programme and based on the positive results we have seen in this comparative study, we can initiate a pivotal Phase lll study and move rapidly toward bringing TW001 to patients.”
TW001, an oral formulation of edaravone, has been developed as a disease-modifying drug for all phenotypes of ALS, and can be used daily to improve patient convenience.
ALS is also called Lou Gehrig’s Disease, which is a progressive neurodegenerative rare condition that causes muscle weakness, disability and eventually death.
The disease, which most frequently attacks people between the ages of 40 and 60, is estimated to affect nearly two people per 100,000 annually.
There is currently no treatment available for ALS.