World News: 13:19 GMT Friday 10th August 2018. [ORPHAZYME A/S via Globe Newswire via SPi World News]
Thomas Blaettler, Chief Medical Officer, said: “.
Michael Benatar, MD, PhD, University of Miami, Principal Investigator of a prior Phase II trial of arimoclomol in SOD1 ALS and Lead International Coordinating Investigator, said: “”.
Lucie Bruijn, PhD, MBA, Chief Scientist at the ALS Association, said: “”.
The randomized and placebo-controlled Phase III trial in ALS is being conducted in North America and Europe and will enroll 231 patients, to be randomized in a 2:1 ratio receiving either arimoclomol or placebo for up to 76 weeks. Patients completing the trial will be offered participation in an open-label extension trial.
The primary objective of the present trial is to determine the efficacy of chronic treatment with arimoclomol compared to placebo over 76 weeks in subjects with ALS as assessed with a combined assessment of function and survival (CAFS). Important secondary endpoints include survival, change in ALSFRS-R, and slow vital capacity (SVC).
A total of 30 sites are planned in the US, Canada and Europe.
Results from the Phase III trial are expected in H1 2021.
Anders Hinsby, CEO +45 31 44 31 39
Globe Newswire: 13:19 GMT Friday 10th August 2018
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