Drug Company Working Group reviews new approaches for accelerating clinical trials, tirasemtiv updates
The discussion participants included Elizabeth McNeil, Biogen; Jinsy Andrews, Cytokinetics; David Ennist, Origent Data Sciences Inc.; and Ammar Al-Chalabi, Dipstat of King’s College London. The meeting was held in Vancouver, Canada, last month.
The discussions revolved around ALS, a progressive neurodegenerative disease that damages the nerve cells located in the spinal cord and the brain. Within a few years after receiving their diagnosis, ALS patients lose the power to move and control their muscles, leading to paralysis and death. Currently, there is no cure for the disease, and there is just one FDA-approved drug that slightly extends patients’ lifespans.
To develop more solutions for the disease, Andrews gave an update about tirasemtiv. This calcium activator works with muscles and may be a symptomatic treatment for ALS. The new treatment has completed testing in a large phase III trial, Vitality-ALS, in July 2015. The next trial is scheduled for later this year.
Scientists are working to develop a new methodology study that will compare and contrast the outcome measures of ALS to various speed trials. The goal is to see where the outcomes reach a higher standard -- leading to better results while treating ALS patients.