ALBRIOZA Commercial Launch
•
.
PHOENIX Trial Design for RELYVRIO
Slightly broader inclusion-exclusion criteria than CENTAUR; substantially greater statistical power
Stratified PHOENIX based on whether people meet CENTAUR inclusion criteria or not
Plan to analyze subset of participants who meet CENTAUR criteria as well as the broader population
RELYVRIO
Screen for eligibility
Key inclusion criteria:
•
Clinically definite or clinically probable
ALS by El Escorial criteria (2-4 body
areas with clinical signs consistent with
ALS)
•
<24 months from symptom onset
•
Slow vital capacity (SVC) >55%
•
Riluzole/edaravone use permitted
Randomization 3:2
(n = 664)
Placebo
Randomized Phase
48 weeks
*40 item assessment questionnaire which provides a subjective health measure to specifically assess quality of life for patients with ALS.
Primary Efficacy Outcomes
•
ALSFRS-R
Safety and tolerability
Secondary Efficacy Outcomes
•
ALSAQ-40*
•
Overall Survival
Slow vital capacity (SVC)
AMYLYX 21View entire presentation